Parsippany, NJ, United States
Teva Pharmaceuticals USA recalls
85 recalls recorded since 2018, most recently on 29 September 2026. 23 are listed as ongoing. Status and classification are as published by the FDA.
Recalls85
Ongoing (FDA)23
Terminated or completed62
Class I (FDA)3
Ongoing Class II Drugs
- Recall started
- 29 September 2026
- Reason
- Presence of Foreign Tablets/Capsules
- Distribution
- US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0038-2027
- Metoclopramide Tablets, USP, 5 mg, [100 or 500] Tablets per bottle, Rx Only, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC 100 Tablets: 0093-2204-01; NDC 500 Tablets: 0093-2204-05
Ongoing Class II Drugs
- Recall started
- 24 August 2026
- Reason
- Presence of Foreign Tablets/Capsules
- Distribution
- U.S. Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0834-2026
- traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactured in Croatia By: Pliva Hrvatska d.o.o, Zagreb, Croatia, Manufactured For: Teva Pharmaceuticals, Parsippany, NJ 07054, NDC 50111-560-01
Ongoing Class II Drugs
- Recall started
- 24 April 2026
- Reason
- Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0519-2026
- Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing: 8-mL vial of 30 mg strength, a pre-filled syringe containing 2 mL of diluent, one vial adapter, and one
Ongoing Class II Drugs
- Recall started
- 6 April 2026
- Reason
- Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
- Distribution
- Nationwide in the USA, Puerto Rico and Virgin Islands
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0521-2026
- Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs NDC 0555-1054-60; b) 30-count carton, NDC 0555-1054-86, with 3X10 blister pack NDC 0555-1054-60; Rx
Ongoing Class II Drugs
- Recall started
- 19 March 2026
- Reason
- CGMP Deviations: use of an unapproved raw material
- Distribution
- Within U.S
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0473-2026, D-0472-2026, D-0474-2026
- Clonidine Transdermal System, USP, 0.2 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc
- Clonidine Transdermal System, USP, 0.1 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx Only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc
- Clonidine Transdermal System, USP, 0.3 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc
Ongoing Class II Drugs
- Recall started
- 17 March 2026
- Reason
- Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0405-2026, D-0404-2026, D-0406-2026
- Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For:
- Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For:
- Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For:
Ongoing Class II Drugs
- Recall started
- 29 January 2026
- Reason
- Failed Dissolution Specifications
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0355-2026, D-0354-2026, D-0357-2026, D-0356-2026
- Metoprolol Succinate Extended-Release Tablets, 50 mg, 100 tablets bottles (NDC: 45963-676-11) and 1,000 tablets bottles (NDC: 45963-676-96), Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054
- Metoprolol Succinate Extended-Release Tablets, 25 mg, 100 tablets bottles (NDC: 45963-709-11) and 1,000 tablets bottles (NDC: 45963-709-96), Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054
- Metoprolol Succinate Extended-Release Tablets, 200 mg, 100 tablets bottles, Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054, NDC: 45963-678-11
- Metoprolol Succinate Extended-Release Tablets, Rx Only, 100 mg, 100 tablets bottles (NDC: 45963-677-11) and 1,000 tablets bottles (NDC: 45963-677-96), Teva Pharmaceuticals, Parsippany, NJ 07054.
Ongoing Class II Drugs
- Recall started
- 12 January 2026
- Reason
- Superpotent and Subpotent
- Distribution
- FL, OH, PR & MS
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0446-2026, D-0445-2026
- Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs, Rx only, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2436-15 (carton), NDC 0591-2436-45 (blister pack).
- Isotretinoin Capsules, USP, 30 mg, Rx Only, 10 count Prescription Pack, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2435-15 (carton), NDC 0591-2435-45 (blister pack).
Ongoing Class III Drugs
- Recall started
- 7 November 2025
- Reason
- Defective Container - A defect in the side-seal which allows leakage of product.
- Distribution
- U.S. Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0198-2026
- Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis Laboratories, Inc, Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc., Parsippany, NJ
Ongoing Class II Drugs
- Recall started
- 13 October 2025
- Reason
- Subpotent drug; Clavulanate Potassium component
- Distribution
- Distributed in three (3) States: MS, OH, CA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0151-2026
- Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg per 5mL, 100 mL (when reconstituted), Rx only, manufactured in Canada by: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva
Ongoing Class II Drugs
- Recall started
- 7 October 2025
- Reason
- CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
- Distribution
- U.S. Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0105-2026, D-0104-2026, D-0106-2026
- Prazosin Hydrochloride, Capsules, USP, 2 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4068-01, b) 1000 Capsules, NDC 0093-4068-10
- Prazosin Hydrochloride, Capsules, USP, 1 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4067-01, b) 1000 Capsules, NDC 0093-4067-10
- Prazosin Hydrochloride, Capsules, USP, 5 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4069-01, b) 250 Capsules, NDC 0093-4069-52, c) 500 Capsules, NDC 0093-
Ongoing Class II Drugs
- Recall started
- 23 May 2025
- Reason
- Presence of foreign tablets/capsules.
- Distribution
- USA Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0473-2025
- Metoclopramide Tablets, USP 10 mg, 100-count bottle, Rx only, Manufactured in Croatia by Pliva Hrvatska, d.o.o., Zageb, Croatia, Manufactured for Teva Pharmaceuticals, Parsippany, NJ 07054, NDC 0093-2203-01.
Ongoing Class II Drugs
- Recall started
- 10 January 2025
- Reason
- Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
- Distribution
- Product was distributed nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0218-2025
- Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syringe, packaged as a) 1 syringe in 1 CARTON, NDC 63459-910-11, Blister NDC 63459-910-12; (b)10 syringes in 1 CARTON, NDC 63459-910-15, Blister NDC
Ongoing Class II Drugs
- Recall started
- 8 August 2024
- Reason
- Superpotent Drug
- Distribution
- Product was distributed nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0637-2024
- Testosterone Gel, 1.62%, (Alcohol 80% v/v), 30 unit-dose packets, Rx Only, Teva Pharmaceuticals, USA, Inc. North Wales, PA 19454, NDC 0591-2925-30. Packet NDC # 0591-2925-32 Carton NDC # 0591-2925-30
Ongoing Class II Drugs
- Recall started
- 28 June 2024
- Reason
- Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits.
- Distribution
- Nationwide in the USA and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0601-2024
- Fludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 100 Tablets per bottle, Manufactured in Canada By: Patheon, Inc., Mississauga, ON, Canada L5N 7K9, Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19
Ongoing Class II Drugs
- Recall started
- 4 June 2024
- Reason
- Subpotent Drug
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0561-2024
- Amoxicillin and Clavulanate Potassium Tablets USP, Chewable 400mg/57mg, 20-count bottles, Rx only, Manufactured in Canada By: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc.
Ongoing Class II Drugs
- Recall started
- 28 March 2024
- Reason
- Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0439-2024
- Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054. Blister Pack NDC 0591-2436-45, Carton NDC 0591-2436-15
Terminated Class II Drugs
- Recall started
- 7 March 2024
- Terminated
- 6 March 2025
- Reason
- Failed Dissolution Specifications
- Distribution
- USA nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0428-2024
- Tri-Lo-Sprintec (norgestimate and ethinyl estradiol) tablets USP - triphasic regimen, packaged in carton containing 3 Blister Cards, 28 Tablets Each, Rx only, Teva Pharmaceuticals USA, INC, North Wales, PA 19454, NDC 009
Ongoing Class III Drugs
- Recall started
- 25 January 2024
- Reason
- Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
- Distribution
- nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0321-2024, D-0322-2024
- Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carton contains 3 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454,
- Nortrel 7/7/7 (norethindrone and ethinyl estradiol tablets USP- triphasic regimen), packaged in cartons, each carton contains 6 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North
Ongoing Class II Drugs
- Recall started
- 8 January 2024
- Reason
- Failed Dissolution Specifications
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0275-2024
- Budesonide Extended-Release Tablets 9mg, 30-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 0591-
Terminated Class III Drugs
- Recall started
- 10 November 2023
- Terminated
- 3 June 2024
- Reason
- OOS for viscosity
- Distribution
- USA nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0127-2024
- Testosterone Gel, 1.62% CIII (Alcohol 80% v/v), packaged in 30 unit-dose packets per carton, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0591-2926-30
Terminated Class II Drugs
- Recall started
- 5 July 2023
- Terminated
- 10 January 2024
- Reason
- Failed Moisture Limits: Water (moisture) content above the approved product specifications.
- Distribution
- Product was distributed to 3 wholesalers/distributors who further distributed the product Nationwide in the USA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0913-2023
- Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0093-8199-28
Terminated Class III Drugs
- Recall started
- 27 April 2023
- Terminated
- 29 February 2024
- Reason
- Labeling: Incorrect or Missing Package Insert
- Distribution
- US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0769-2023, D-0768-2023, D-0767-2023, D-0770-2023, D-0766-2023
- Fentanyl Buccal Tablets CII, 600mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-637-28
- Fentanyl Buccal Tablets CII, 400mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-636-28
- Fentanyl Buccal Tablets CII, 200mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-635-28
- Fentanyl Buccal Tablets CII, 800mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-638-28
- Fentanyl Buccal Tablets CII, 100mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-634-28
Terminated Class III Drugs
- Recall started
- 27 March 2023
- Terminated
- 23 August 2023
- Reason
- Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.
- Distribution
- USA Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0510-2023
- Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 30 packets, Rx only, Distributed By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, Carton NDC 0093-7487-56, Packet NDC 0093-7487-19
Terminated Class II Drugs
- Recall started
- 23 February 2023
- Terminated
- 28 November 2023
- Reason
- Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified impurity.
- Distribution
- Nationwide in the U.S.A.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0469-2023
- Clear Eyes, Once Daily, Eye Allergy Itch Relief, olopatadine hydrochloride ophthalmic solution, USP, 0.2%, Antihistamine, 2.5 mL (0.085 fl oz) bottle, Sterile, Distributed by Medtech Products Inc. Tarrytown, NY 10591, A
Terminated Class II Drugs
- Recall started
- 22 February 2023
- Terminated
- 6 December 2023
- Reason
- CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
- Distribution
- CA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0441-2023
- Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, RX only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 070
Terminated Class II Drugs
- Recall started
- 29 August 2022
- Terminated
- 14 August 2023
- Reason
- Labeling: Label Error on Declared Strength; A sealed 100-count bottle labeled with 15 mg actually contained 100 tablets of 20 mg strength of the drug product.
- Distribution
- Nationwide in the US.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1539-2022
- Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product), 15 mg, Rx Only, 100 tablets per bottle, Teva Pharmaceut
Terminated Class II Drugs
- Recall started
- 23 August 2022
- Terminated
- 7 September 2023
- Reason
- CGMP Deviations: A foreign matter identified as teflon was found in the Active Pharmaceutical Ingredient (API) used in the manufacture of Neomycin Sulfate Tablets, USP 500 mg.
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1473-2022
- Neomycin Sulfate Tablets, USP 500 mg , 100-count bottles, Rx only, Distributed by: TEVA PHARMACEUTICALS USA, INC North Wales, PA 19454, NDC 0093-1177-01
Terminated Class III Drugs
- Recall started
- 22 July 2022
- Terminated
- 12 April 2023
- Reason
- Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
- Distribution
- Distributed in Ohio
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1334-2022
- Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories, NDC 68001-313-56
Terminated Class II Drugs
- Recall started
- 21 July 2022
- Terminated
- 18 April 2023
- Reason
- Failed Dissolution Specifications: below specification limits for dissolution.
- Distribution
- Nationwide in the USA and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1303-2022, D-1302-2022
- Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30-count bottles, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL USA 33314, USA, Distributed by: Actavis Pharma Inc., Pa
- Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 180 mg, 30-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, USA; Distributed by: Actavis Pharma, Inc., Parsip
Terminated Class II Drugs
- Recall started
- 29 June 2022
- Terminated
- 15 March 2024
- Reason
- Superpotent Drug: Out of specification assay result was obtained during stability testing.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1289-2022
- Testosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose, Rx Only, 30 unit-dose packets per box. Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, US 84108, USA, Distributed by: Actavis Pharm
Terminated Class II Drugs
- Recall started
- 14 June 2022
- Terminated
- 27 April 2023
- Reason
- Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution.
- Distribution
- Nationwide in the U.S.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1156-2022
- Tretinoin Capsules, 10 mg, Rx Only, 100 capsules per bottle, Teva Pharmaceuticals USA Inc., North Wales, PA, 19454, NDC 0555-0808-02.
Terminated Class III Drugs
- Recall started
- 18 May 2022
- Terminated
- 8 December 2023
- Reason
- Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
- Distribution
- Product was distributed nationwide in the US Market
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0988-2022
- Alprostadil Injection USP 500 mcg/mL, 1 mL Single Dose Vial, 5 vials per Carton, Rx Only, Carton NDC 0703-1501-02, Distributed by: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, Vial NDC 0703-1501-01
Terminated Class I Drugs
- Recall started
- 11 May 2022
- Terminated
- 26 February 2024
- Reason
- Failed Dissolution Specifications- Low Out-Of-Specification results obtained during stability testing.
- Distribution
- Distributed Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0992-2022
- Anagrelide Capsules USP, 0.5 mg, 100-count bottles, Rx Only, Manufactured in India For: TEVA PHARMACEUTICALS USA, Inc., North Wales, PA 19454. NDC 0172-5241-60.
Terminated Class II Drugs
- Recall started
- 15 April 2022
- Terminated
- 25 May 2023
- Reason
- cGMP Deviations
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0794-2022
- Lidocaine 2.5% and Prilocaine 2.5% Cream, USP, packaged in a) 5 g tubes (NDC 0591-2070-72), b) 30 g tubes (NDC 0591-2070-30), Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, USA, Distributed by: Actavi
Terminated Class I Drugs
- Recall started
- 29 March 2022
- Terminated
- 20 June 2023
- Reason
- Presence of Particulate Matter: Product was found to contain silica and iron oxide
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0765-2022
- IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use, 5mL Single Dose Vial, Rx Only, Teva Pharmaceuticals, USA, Inc., North Wales, PA 19454, NDC 0703-4154-11.
Terminated Class II Drugs
- Recall started
- 18 January 2022
- Terminated
- 21 December 2022
- Reason
- Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0461-2022
- Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/10 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, USA, Distributed by: Actavis Ph
Terminated Class II Drugs
- Recall started
- 10 January 2022
- Terminated
- 21 December 2022
- Reason
- Failed Dissolution Specifications; Low Out of specification (OOS) results for dissolution.
- Distribution
- nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0520-2022
- Tretinoin Capsules, 10 mg, 100 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-0808-02
Terminated Class III Drugs
- Recall started
- 7 January 2022
- Terminated
- 1 June 2023
- Reason
- Mislabeling
- Distribution
- USA Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0522-2022, D-0521-2022
- Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx Only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970, Manufactured For: Teva Pharmaceuticals USA Inc
- Mimvey (estradiol and norethindrone acetate tablets USP), 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970, Manufactured For: Teva Pharmaceuticals USA In
Terminated Class II Drugs
- Recall started
- 31 December 2021
- Terminated
- 4 June 2024
- Reason
- Lack of Assurance of Sterility
- Distribution
- Methylprednisolone, TN Norepinephrine BItartrate - MS, OH
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0370-2022, D-0371-2022
- MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL (40mg/mL), 10 mL Multiple-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsi
- Norepinephrine Bitartrate Injection USP 4 mg/4 mL (1 mg/mL), 4 mL Single-Dose Vials, 10 vials per carton, Rx Only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0703-1153-03.
Terminated Class II Drugs
- Recall started
- 16 December 2021
- Terminated
- 4 November 2022
- Reason
- Subpotent
- Distribution
- nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0294-2022
- Penicillin V Potassium for Oral Solution, USP 125 mg (200,000 U) per 5 mL a) 100 mL (NDC 00093-4125-73) and b) 200 mL (NDC 00093-4125-74) (when mixed) bottles, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc. No
Terminated Class II Drugs
- Recall started
- 8 December 2021
- Terminated
- 1 June 2023
- Reason
- Defective Container: The notch in the cap that fits into the nozzle of the dropper could break off and block the dropper possibly resulting in the product not dispensing.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0373-2022
- Brinzolamide Ophthalmic Suspension, USP 1%, packaged as a)10 ml dropper bottles (NDC 0591-2127-79), and b) 15 ml dropper bottles (NDC 0591-2127-12), Rx Only, Manufactured in India By: Indoco Remedies Limited Verna, Goa -
Terminated Class III Drugs
- Recall started
- 28 October 2021
- Terminated
- 27 February 2023
- Reason
- Failed Impurities/Degradation Specifications
- Distribution
- Nationwide and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0235-2022
- Clonidine Transdermal System, USP 0.1 mg/day, 4 patches per carton, Rx only, Manufactured by: Actavis Laboratories, UT Inc., Salt Lake City, UT, Distributed by: Actavis Pharma, Inc., Parsippany, NJ NDC 0591-3508-04
Terminated Class II Drugs
- Recall started
- 27 October 2021
- Terminated
- 21 December 2022
- Reason
- Labelling: Incorrect Exp. Date
- Distribution
- Distributed Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0232-2022
- Cartia XT (Diltiazem Hydrochloride Extended-Release Capsules, USP) 120 mg, Rx Only, 90 capsules, labelled as (a) Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054; (b) Manufactured By: Actavis Laborat
Terminated Class II Drugs
- Recall started
- 22 September 2021
- Terminated
- 16 February 2023
- Reason
- Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
- Distribution
- USA Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0023-2022, D-0022-2022, D-0024-2022, D-0025-2022, D-0021-2022
- AirDuo Digihaler 55/14 (fluticasone propionate 55 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC Frazer, PA 19355, Manufactured in Ireland, NDC 59310-111-06
- AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale, Rx Only, Mktd by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-530-08
- AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd. by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-129-06.
- AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-136-06
- AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale, Rx Only, Mktd by: Teva Respiratory, LLC , Frazer, PA 19355, Manufactured in Ireland, NDC 59310-520-0
Terminated Class II Drugs
- Recall started
- 29 July 2021
- Terminated
- 4 June 2024
- Reason
- Lack of Assurance of Sterility
- Distribution
- Product was distributed Nationwide, including Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0738-2021, D-0730-2021, D-0737-2021, D-0731-2021, D-0739-2021, D-0736-2021, D-0743-2021, D-0734-2021, D-0747-2021, D-0744-2021, D-0745-2021, D-0732-2021 and 7 more
- Epoprostenol Sodium for Injection, 1.5 mg/vial, 10 mL vials, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-1995-01
- DAUNOrubicin Hydrochloride Injection 20 mg/4mL, 4mL Single Dose vials, 10 in 1 carton, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618 Vial NDC# 0703-5233-11, Carton NDC # 0703-5233-13
- Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-5145-01
- Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0031-01), and b) 5mL Multi Dose Vials (NDC 0703-0043-01), and c) 10 mL Multi-Dose Vials (NDC 0703-0045-01), Rx o
- Norepinephrine Bitartrate Injection, USP 4 mg/4 mL, 4 mL single dose vials, packaged in 10 vial cartons (NDC 0703-1153-03) Rx only, Teva Pharmaceuticals USA Inc. North Wales, PA 19454, vial NDC 0703-1153-01
- Octreotide Acetate Injection 1000 mcg/5mL, 5 mL multi-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3333-01
- Methylprednisolone Acetate Injectable Suspension USP, 80 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0051-01), and b) 5mL Multi Dose Vials (NDC 0703-0063-01), Rx only, TEVA PHARMACEUTICALS USA, INC. North Wales,
- Idarubicin Hydrochloride Injection 20 mg/20 mL, 20 mL single-dose vial, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-4156-11
- and 11 more product lines
Terminated Class II Drugs
- Recall started
- 29 July 2021
- Terminated
- 4 November 2022
- Reason
- CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate.
- Distribution
- Product was distributed nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0775-2021, D-0776-2021, D-0774-2021
- Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, NDC 70199-014-01
- Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, NDC 57237-266-01
- Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054,
Terminated Class I Drugs
- Recall started
- 18 June 2021
- Terminated
- 4 April 2022
- Reason
- Presence of Particulate Matter: Complaint received of a glass particle observed inside the vial. The vial was returned to Teva for further analysis where two other particulates were found and identified as one (1) grey silicone particle and one (1) translucent, colorless cotton fiber.
- Distribution
- Distributed Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0661-2021
- Topotecan Injection 4 mg/4mL (1 mg/mL), Single-Dose vial, Teva Pharmaceuticals USA, Inc. North Whales, PA 19454, Carton NDC# 0703-4714-01, Vial NDC# 0703-4714-71
Terminated Class II Drugs
- Recall started
- 26 April 2021
- Terminated
- 4 June 2024
- Reason
- Lack of Assurance of Sterility
- Distribution
- Product was distributed nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0375-2021, D-0374-2021, D-0377-2021, D-0378-2021, D-0376-2021
- Haloperidol Decanoate Injection, USP 50 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., North Wales, PA NDC 00703-7121-03
- Leucovorin Calcium for Injection, equivalent to leucovorin 350 mg/vial (20 mg/mL), Rx Only, FOR IM or IV Use, Sterile, Teva Parenteral Medicines, Inc., Irvine, CA NDC 0703-5145-01; ALSO LABELED UNDER: NOVAPLUS, Manufact
- Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial, Rx Only, TEVA Parenteral Medicines, Inc. Irvine, CA 92618 NDC 0703-4502-04
- Haloperidol Decanoate Injection, USP 100 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., North Wales, PA NDC 0703-7131-03
- Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, 10 mL Multiple Dose Vial, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0703-0045-01
Terminated Class III Drugs
- Recall started
- 4 March 2021
- Terminated
- 19 May 2022
- Reason
- Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing.
- Distribution
- Distributed Nationwide in the USA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0309-2021
- Romidepsin Injecton, 27.5 mg/5.5 mL (5 mg/mL) Rx Only, 5.5 ml vial, Teva Pharmaceuticals USA, Inc. NDC 0703-4004-01
Terminated Class II Drugs
- Recall started
- 15 February 2021
- Terminated
- 26 August 2021
- Reason
- Chemical contamination; Unknown brown residue adhering to the inside of one vial.
- Distribution
- Nationwide, including Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0297-2021
- Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 25x2mL Single Dose Vials, Rx only, Distributed by Teva Pharmaceuticals, USA, Inc., Parsippany, NJ Vial NDC 0703-4502-01 (vial) NDC# 0703-4502-04 (tray)
Terminated Class II Drugs
- Recall started
- 10 February 2021
- Terminated
- 15 May 2024
- Reason
- Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
- Distribution
- Product was distributed nationwide in the USA and Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0280-2021, D-0277-2021, D-0273-2021, D-0272-2021, D-0271-2021, D-0279-2021, D-0275-2021, D-0281-2021, D-0278-2021, D-0274-2021, D-0284-2021, D-0282-2021 and 3 more
- Epoprostenol Sodium for Injection, 1.5 mg/vial (1,500,000 ng), 10 mL vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-1995-01.
- Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial NDC 0703-4502-01), packaged in 25 x 2 mL Single-Use Vials per tray (NDC 0703-4502-04), Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618.
- Sterile Diluent for Epoprostenol Sodium for Injection, 50 mL vial (NDC 0703-9258-01), packaged in 2X50ML per tray (NDC 0703-9258-09), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454.
- Desmopressin Acetate Injection USP, 4 mcg/mL, 1 mL Preserved Vial (NDC 0703-5051-01), packaged in 10X1 mL Vials per Tray (NDC 0703-5051-03), Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
- Dacarbazine for Injection USP, 200 mg, Single Use Vial (NDC 0703-5075-01), packaged in 10X20 ML Single Use Vials per tray (NDC 0703-5075-03); Rx only, TEVA Pharmaceuticals USA, INC., North Wales, PA 19454.
- Vecuronium Bromide for Injection, 10 mg, 1 mg/mL when reconstituted to 10 mL, 10 mL Vial (NDC 0703-2914-01), packaged in 10 x 10 mL Vials per tray (NDC 0703-2914-03), Rx only, Teva Pharmaceuticals USA, Inc., North Wales,
- MethyIPREDNISolone Acetate Injectable Suspension USP, 40 mg/mL, 1 mL Single-Dose Vial (NDC 0703-0031-01), packaged in 25X1ML per tray (NDC 0703-0031-04), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454.
- MethyIPREDNISolone Acetate Injectable Suspension USP, 80 mg/mL, 1 mL Single-Dose Vial (NDC 0703-0051-01), packaged in 25X1ML vials per tray (NDC 0703-0051-04), Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19
- and 7 more product lines
Terminated Class III Drugs
- Recall started
- 11 November 2020
- Terminated
- 24 June 2021
- Reason
- Superpotent Drug: High out-of-specification assay results were obtained during stability testing.
- Distribution
- Product was distributed Nationwide in the USA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0100-2021
- Testosterone Gel 1%, 2.5 grams per unit dose, packaged in 2.5 gram Unit-Dose Packets (NDC 0591-3216-17); 30 Unit-Dose Packets per carton (NDC 0591-3216-30), Rx only, Manufactured by: Actavis Laboratories UT, Inc., Salt L
Terminated Class II Drugs
- Recall started
- 28 October 2020
- Terminated
- 26 August 2021
- Reason
- Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing.
- Distribution
- Nationwide in the U.S. and PR
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0069-2021
- Mesalamine Delayed-Release Tablets, USP 1.2 gram, 120 tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories, FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma Inc., Parsippany, NJ 07054, ND
Terminated Class II Drugs
- Recall started
- 4 September 2020
- Terminated
- 26 August 2021
- Reason
- Failed Stability Specifications: Below specification result for buprenorphine release rate.
- Distribution
- Nationwide in the U.S. and PR
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0003-2021
- Buprenorphine Transdermal System 5 mcg/hour, 4 transdermal systems/4 disposal units per carton, Rx Only, Manufactured by: 3M Drug Delivery Systems, 19901 Nordhoff street, Northridge, CA 91324 USA, Manufactured for: Teva
Terminated Class II Drugs
- Recall started
- 24 August 2020
- Terminated
- 16 December 2021
- Reason
- CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.
- Distribution
- Nationwide in the U.S. and Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0013-2021, D-0012-2021, D-1566-2020
- Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle when mixed, NDC 0093-4177-73, b) 200 mL bottle when mixed, NDC 0093-4177-74, Teva Pharmaceuticals USA,
- Cephalexin for Oral Suspension, USP 125 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle when mixed, NDC 0093-4175-73, b) 200 mL bottle when mixed, NDC 0093-4175-74, Teva Pharmaceuticals USA,
- Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, 100 mL bottle when mixed, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-4177-73.
Terminated Class II Drugs
- Recall started
- 14 July 2020
- Terminated
- 7 July 2021
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp date on the individual transdermal pouches but not in the carton.
- Distribution
- Nationwide United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1492-2020
- Lidocaine Patch 5%, packaged in 30-count cartons, Rx only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 0591-3525-30
Terminated Class II Drugs
- Recall started
- 2 June 2020
- Terminated
- 12 April 2024
- Reason
- CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
- Distribution
- Product was distributed throughout the United States, including Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1331-2020, D-1332-2020
- Metformin Hydrochloride Extended - Release Tablets, USP, 500 mg, a) 100 (NDC 62037-571-01) and b) 1,000 (NDC 62037-571-10) count bottles, Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa, Dist
- Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, a) 100 (NDC 62037-577-01) and b) 1000 (NDC 62037-577-10), Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa, Distributed by: Actavi
Terminated Class II Drugs
- Recall started
- 22 May 2020
- Terminated
- 25 May 2021
- Reason
- Some bottles may contain mixed strengths of the product.
- Distribution
- Nationwide within the United State and Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1285-2020, D-1286-2020, D-1287-2020
- Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed Amphetamine Salts Product), 5 mg, 100 count bottles, Rx Only, Teva Pharmaceuticals USA, INC. North Wa
- Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed Amphetamine Salts Product), 15 mg, 100 count bottles, Rx Only, Teva Pharmaceuticals USA, INC. North W
- Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed Amphetamine Salts Product), 20 mg, 100 count bottles, Rx Only, Teva Pharmaceuticals USA, INC. North W
Ongoing Class II Drugs
- Recall started
- 25 March 2020
- Reason
- CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
- Distribution
- Bulk product was distributed to one re-packager in California.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1101-2020, D-1102-2020, D-1100-2020
- LOSARTAN POTASSIUM TABLETS, USP 50 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia, Malta NDC 0591-3746-00
- LOSARTAN POTASSIUM TABLETS, USP 100 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia, Malta NDC 0591-3747-00
- LOSARTAN POTASSIUM TABLETS, USP 25 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia Malta NDC 0591-3745-00
Terminated Class II Drugs
- Recall started
- 5 March 2020
- Terminated
- 19 November 2020
- Reason
- CGMP Deviations: Precautions taken due to Out-of-specification for trigger force for a non-marketed lot number that shares the same component.
- Distribution
- Product was distributed to 1 wholesaler who still had all units within their possession and had not shipped or further distributed any of the product.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1260-2020
- Epinephrine Injection USP, 0.3 mg (Auto-Injector), 0.3 mg/ 0.3 mL pre-filled syringe, Rx Only, Manufactured for Teva Pharmaceuticals USA, Inc. North Wales, PA 19454. NDC 0093-5986-27
Terminated Class II Drugs
- Recall started
- 20 February 2020
- Terminated
- 6 October 2020
- Reason
- Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing.
- Distribution
- Nationwide in the USA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0862-2020
- Mesalamine Delayed-Release Tablets, USP, 1.2 gram, 120-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; NDC 0
Terminated Class III Drugs
- Recall started
- 28 January 2020
- Terminated
- 19 May 2021
- Reason
- Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets contain language relative to a 25 mg dosing titration that necessitates the use of a scored 50 mg tablet.
- Distribution
- U.S.A. Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0851-2020
- Tramadol Hydrochloride Tablets USP CIV, 50 mg, packaged in a) 100-count bottles (NDC 0093-0058-01), b) 500-count bottles (NDC 0093-0058-05), RX only, Manufactured in Czech Republic for: Teva Pharmaceuticals USA, Inc., N
Terminated Class II Drugs
- Recall started
- 27 January 2020
- Terminated
- 10 December 2020
- Reason
- GMP Deviations: Product bottle may be absent of desiccant.
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0830-2020, D-0831-2020
- Desmopressin Acetate Tablets, 0.1 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories, Inc. Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc. Parisppany, NJ 07054 USA, NDC 0591-2464-01
- Desmopressin Acetate Tablets, 0.2 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories, Inc. Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc. Parisppany, NJ 07054 USA, NDC 0591-2465-01
Terminated Class II Drugs
- Recall started
- 27 January 2020
- Terminated
- 3 November 2020
- Reason
- CGMP deviations: Product bottle may be absent of desiccant.
- Distribution
- USA Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0837-2020, D-0836-2020
- Methylphenidate hydrochloride Extended-Release ablets USP (CII), 27 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 62037-734-01
- Methylphenidate hydrochloride Extended-Release ablets USP (CII), 18 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 62037-725-01
Terminated Class II Drugs
- Recall started
- 4 November 2019
- Terminated
- 17 November 2020
- Reason
- Presence of foreign substance: Brown/black particles found during stability testing.
- Distribution
- Product was distributed to wholesalers/distributors throughout the United States.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0518-2020
- Valganciclovir Hydrochloride for Oral Solution, 50 mg/mL, 100 mL (3.4 fl. oz.) bottle, Rx only, Manufactured for: Actavis Laboratories FL. Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany
Terminated Class III Drugs
- Recall started
- 6 September 2019
- Terminated
- 19 May 2020
- Reason
- GMP Deviation: lot not intended for commercial distribution.
- Distribution
- Product was distributed to 42 wholesalers and 11 retailers who may have further distribute the product throughout the United States, including Hawaii and Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0131-2020
- Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30 count bottle, Rx only, Manufactured by: Actabis Laboratories FL, Inc., Fort Lauderdale, FL, Distributed by: Actavis Pharma, Inc., Parsippany, NJ N
Ongoing Class II Drugs
- Recall started
- 6 June 2019
- Reason
- CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
- Distribution
- Nationwide by 4 major distributors.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1455-2019, D-1456-2019
- LOSARTAN POTASSIUM 50 mg TABLET BULK 90 count bottles and 1000 count bottles, NDC 00591-3746-00
- LOSARTAN POTASSIUM 100 mg TABLET BULK 90 count bottles, NDC 00591-3747-00
Terminated Class II Drugs
- Recall started
- 12 April 2019
- Terminated
- 8 July 2020
- Reason
- Subpotent Product: assay results for Amoxicillin were below the specification limits.
- Distribution
- Nationwide in the USA and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1205-2019
- Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in (a) 150 mL bottle (NDC 0093-4150-80) (b) 80 mL bottle (NDC 0093-4150-79), Rx Only, Manufactured in Canada By: Teva Canada Limited Toronto, Canada, M1B2K9,
Terminated Class III Drugs
- Recall started
- 11 March 2019
- Terminated
- 15 November 2019
- Reason
- Subpotent Drug.
- Distribution
- Nationwide in the United States.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1006-2019
- Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100 tablets (10 blister cards of 10 tablets each), Rx only, Manufactured in Israel By: Teva Pharmaceutical Ind. Ltd. Jerusalem, 9777402, Israel, Manufac
Terminated Class II Drugs
- Recall started
- 19 December 2018
- Terminated
- 31 August 2020
- Reason
- Failed dissolution specifications
- Distribution
- U.S.A. nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0381-2019
- Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 40 mg/25 mg, packaged in a) 30-count bottle (NDC 0093-7617-56), b) 90-count bottle (NDC 0093-7617-98), Rx only, Manufactured In Israel By: Teva Pharmaceutical, IND. L
Ongoing Class II Drugs
- Recall started
- 27 November 2018
- Reason
- CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
- Distribution
- USA Nationwide including Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0303-2019, D-0305-2019, D-0306-2019, D-0310-2019, D-0304-2019, D-0308-2019, D-0309-2019, D-0307-2019
- Amlodipine and Valsartan Tablets 5 mg/160 mg, (a) 30-count bottles (NDC 0093-7690-56) & 90-count bottles (NDC 0093-7690-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, M
- Amlodipine and Valsartan Tablets 5 mg/320 mg, (a) 30-count bottles (NDC 0093-7692-56) & 90-count bottles (NDC 0093-7692-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, M
- Amlodipine and Valsartan Tablets 10 mg/320 mg (a) 30-count bottles (NDC 0093-7693-56) & 90-count bottles (NDC 0093-7693-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel,
- Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/320 mg/25 mg, (a) 30-count bottles (NDC 0093-7809-56) & 90-count bottles (NDC 0093-7809-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD.
- Amlodipine and Valsartan Tablets 10 mg/160 mg, (a) 30-count bottles (NDC 0093-7961-56) & 90-count bottles (NDC 0093-7691-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel,
- Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/12.5 mg, (a) 30-count bottles (NDC 0093-7810-56) & 90-count bottles (NDC 0093-7810-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD
- Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/25 mg, (a) 30-count bottles (NDC 0093-7960-56) & 90-count bottles (NDC 0093-7690-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD.
- Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 5 mg/160 mg/12.5 mg, (a) 30-count bottles (NDC 0093-7807-56) & 90-count bottles (NDC 0093-7807-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LT
Terminated Class II Drugs
- Recall started
- 19 October 2018
- Terminated
- 3 April 2019
- Reason
- Failed dissolution specifications: Out-of-Specification dissolution test result obtained during routine stability testing.
- Distribution
- U.S.A. Nationwide including Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0129-2019
- Metoprolol Succinate Extended Release Tablets, USP 50 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054,
Terminated Class II Drugs
- Recall started
- 27 September 2018
- Terminated
- 6 October 2020
- Reason
- Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
- Distribution
- Product was distributed throughout the United States, including Hawaii and Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0244-2019
- Alprostadil Injection USP 500 micrograms/mL 1 mL single use vial, 5 vials per carton, Rx only, TEVA Pharmaceuticals USA, Inc., North Wales, PA --- NDC 0703-1501-02
Terminated Class II Drugs
- Recall started
- 21 September 2018
- Terminated
- 1 May 2019
- Reason
- Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.
- Distribution
- Distributed nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0001-2019
- Clozapine Orally Disintegrating Tablets, 12.5 mg, 100-count bottles, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5416-01 Yellow, round, flat-faced, beveled-edge, unscored tablet. Debossed w
Terminated Class II Drugs
- Recall started
- 20 September 2018
- Terminated
- 7 November 2019
- Reason
- Failed Stability Specifications: Out-of-specification test result for water content obtained during routine stability testing.
- Distribution
- Product was distributed throughout the United States to various distributors who may have further distributed the product.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0082-2019
- Clonazepam Orally Disintegrating Tablets USP, 2 mg., 60-count carton. RX only. Teva Pharmaceuticals USA, INC. North Whales, PA 19454. NDC 0555-0098-96
Terminated Class II Drugs
- Recall started
- 6 August 2018
- Terminated
- 13 February 2020
- Reason
- Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
- Distribution
- Product was distributed throughout the United States. Bulk product was distributed to Takeda, Deerfield, IL and may have been further distributed.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0097-2019, D-0099-2019, D-0096-2019, D-0098-2019, D-0100-2019, D-0102-2019, D-0101-2019
- Paliperidone Extended Release Tablets 9 mg, packaged in a) 30-count bottle(NDC 0591-3695-30) , b) 90-count bottle (NDC 0591-3695-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Di
- Metformin Hydrochloride Extended Release Tablets, 500 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories, FL Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054,
- Paliperidone Extended Release Tablets 3 mg, packaged in a) 30-count bottle(NDC 0591-3693-30), b) 90-count bottle (NDC-0591-3693-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Dis
- Fortamet (metformin HCl) extended release tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Shionogi Inc., Florham Park, NJ 07932, NDC
- Metformin Hydrochloride Extended Release Tablets 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL, 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 ,
- PIO&METFORMIN 15/1000 mg Tab 1 (Pioglitazone and Metformin XT) tablets, Takeda Brand Name: Actoplus Met XR (Pioglitazone and metformin HCl extended -release) tablets, 15 mg/1000 mg, packaged in a fiber drum, Application
- Metformin Hydrochloride Extended Release Tablets 1000 mg, 90-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL, 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 ,
Ongoing Class II Drugs
- Recall started
- 16 July 2018
- Reason
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Distribution
- Product was distributed throughout the United States, including Hawaii and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0982-2018, D-0988-2018, D-0983-2018, D-0989-2018, D-0981-2018, D-0986-2018, D-0987-2018, D-0984-2018, D-0985-2018
- Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/12.5 mg tablets, USP 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 0
- Valsartan Tablets, USP 160 mg, 90-count bottle (NDC 0591-2169-19), 1000-count bottle (NDC 0591-2169-10), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany
- Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/25 mg tablets, USP 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 070
- Valsartan Tablets, USP 320 mg, 90-count bottle (NDC 0591-2170-19), 500-count bottle (NDC 0591-2170-05), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany,
- Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 80 mg/12.5 mg tablets, 90 count-count bottle, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054, ND
- Valsartan Tablets, USP 40 mg, 30-count bottle (NDC 0591-2167-30), 90-count bottle (NDC 0591-2167-19), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, N
- Valsartan Tablets, USP 80 mg, 90-count bottle (NDC 0591-2168-19), 1000-count bottle (NDC 0591-2168-10), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany,
- Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/12.5 mg tablets, USP, 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ
- and 1 more product lines
Terminated Class II Drugs
- Recall started
- 16 July 2018
- Terminated
- 28 March 2019
- Reason
- API material used in the manufacturing of the product did not receive regulatory approval prior to release.
- Distribution
- Product was distributed throughout the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1074-2018
- Omega-3-Acid Ethyl Esters Capsules USP, 1 gram* 120-count bottle Rx Only. Manufactured by: Banner Pharmacaps, Inc. High Point, NC 27265. Manufactured for: Teva Pharmaceuticals USA Inc. North Wales, PA 19454 NDC 0093-540
Terminated Class II Drugs
- Recall started
- 5 July 2018
- Terminated
- 3 April 2019
- Reason
- Failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) test results for below assay and above specification for degradants.
- Distribution
- Nationwide in the USA and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0909-2018
- Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL bottle, Rx Only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108 USA; Distributed by: Actavis Pharmac, Inc., Parsippany, NJ 07054 USA
Terminated Class III Drugs
- Recall started
- 30 April 2018
- Terminated
- 14 January 2019
- Reason
- Failed Stability Specifications
- Distribution
- United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0857-2018
- Lidocaine Patch 5% (700 mg) ,(NDC 0591-3525-11), 30 envelopes containing 1 patch each/ 30 Patches/Carton (NDC 0591-3525-30)
Terminated Class II Drugs
- Recall started
- 19 March 2018
- Terminated
- 15 October 2019
- Reason
- Defective Container: This recall is being initiated due to product complaints regarding difficulty in dispensing the tablet from the applicator.
- Distribution
- Distributed within the United States and Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0620-2018
- Estradiol Vaginal Inserts, USP 10 mcg, packaged in a) 8 inserts/carton (NDC 0093-3223-08) and b) 18 inserts/carton (NDC 0093-3223-97), Rx only, Teva Women's Health, Inc. Subsidiary of Teva Pharmaceuticals USA, North Wale
Terminated Class III Drugs
- Recall started
- 5 February 2018
- Terminated
- 30 April 2019
- Reason
- Failed impurities/ degradation specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling all lots within expiry due to out of specification (OOS) test result for the lactoside impurity obtained during routine stability testing activities.
- Distribution
- Distributed throughout the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0578-2018
- Fluoxetine Tablets USP, 10 mg, 30-count bottle, Rx only, Manufactured in Israel by: Teva Pharmaceuticals IND, LTD, Jerusalem, 9777402, Israel, Manufactured for: Teva Pharmaceuticals USA, INC., North Wales, PA 19454, NDC
Terminated Class III Drugs
- Recall started
- 29 January 2018
- Terminated
- 5 September 2018
- Reason
- Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
- Distribution
- Distributed nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0540-2018, D-0543-2018, D-0541-2018, D-0542-2018
- Fentanyl Transdermal System. 25 mcg/h, packaged in 5 pouch system cartons (NDC 0591-3198-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsipp
- Fentanyl Transdermal System, 100 mcg/h, packaged in 5 pouch system (NDC 0591-3214-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsippany, NJ
- Fentanyl Transdermal System, 50 mcg/h, packaged in 5 pouch system cartons (NDC 0591-3212-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsipp
- Fentanyl Transdermal System. 75 mcg/h, packaged in 5 pouch system (NDC 0591-3213-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsippany, NJ
Terminated Class II Drugs
- Recall started
- 14 December 2017
- Terminated
- 1 October 2018
- Reason
- Failed Impurities/Degradation Specifications: High out of specification test result for the Moexipril Diketopiperazine impurity was obtained during routine stability testing.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0208-2018
- Moexipril Hydrochloride and Hydrocholorothiazide Tablets USP, 7.5 mg/12.5 mg, 100-count bottle, Rx only, Distributed By: TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0093-5213-01.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.