Baltimore, MD, United States
Lupin Pharmaceuticals Inc. recalls
80 recalls recorded since 2018, most recently on 3 August 2026. 7 are listed as ongoing. Status and classification are as published by the FDA.
Recalls80
Ongoing (FDA)7
Terminated or completed73
Class I (FDA)2
Ongoing Class II Drugs
- Recall started
- 3 August 2026
- Reason
- Failed content uniformity specifications.
- Distribution
- USA Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0789-2026
- Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin Limited, Pithampur (MP) 454 775, INDIA, NDC 68180-956-04.
Ongoing Class II Drugs
- Recall started
- 23 June 2026
- Reason
- CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
- Distribution
- Nationwide within the U.S.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0723-2026
- Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial, Diluent for Glucagon, 1 mL syringe, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin L
Ongoing Class II Drugs
- Recall started
- 4 June 2026
- Reason
- Presence of Foreign Substance
- Distribution
- U.S. Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0655-2026
- prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 mL (NDC 70748-332-02); b) 10 mL (NDC 70748-332-03), c) 15 mL (70748-332-04), Manufactured by: Lupin Limited, Pithampur (M.P) 454 775, INDIA
Ongoing Class II Drugs
- Recall started
- 24 April 2026
- Reason
- Presence of particulate matter: a white thread-like structure in the cartridge
- Distribution
- Nationwide within U.S
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0541-2026
- Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin Limited, Nagpur 441108, INDIA, a) 2 Pens- NDC 70748-346-02; b) 3 Pens - NDC 70
Ongoing Class II Drugs
- Recall started
- 13 November 2025
- Reason
- Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
- Distribution
- FL, MA, MI & OH
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0220-2026
- Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin
Ongoing Class II Drugs
- Recall started
- 5 November 2025
- Reason
- Defective container - seal not adhering to bottles
- Distribution
- Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0227-2026
- Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09.
Terminated Class II Drugs
- Recall started
- 2 July 2025
- Terminated
- 30 July 2026
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
- Distribution
- Nationwide in the US
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0542-2025
- Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL, 34108, United States, Manufactured by: Lupin Limited, Goa 103 722, INDIA,
Terminated Class II Drugs
- Recall started
- 27 June 2025
- Terminated
- 5 January 2026
- Reason
- Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.
- Distribution
- Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0537-2025
- clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01
Ongoing Class II Drugs
- Recall started
- 20 June 2025
- Reason
- Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg.
- Distribution
- Product was distributed nationwide within the United States.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0532-2025
- Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles, Rx only, Mfg for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, Manufactured by: Lupin Limited Nagpur-441 108, INDIA, NDC 68180-519-01
Terminated Class II Drugs
- Recall started
- 10 April 2025
- Terminated
- 5 January 2026
- Reason
- Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability study.
- Distribution
- USA nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0377-2025
- clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States, Manufactured By: Lupin Limited, Nagpur, 441 108 INDIA, NDC 681
Terminated Class II Drugs
- Recall started
- 20 December 2024
- Terminated
- 17 February 2026
- Reason
- Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.
- Distribution
- One US distributor in Ohio.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0167-2025
- Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited, Pithampur (M.P)- 454 77
Terminated Class II Drugs
- Recall started
- 23 October 2024
- Terminated
- 5 January 2026
- Reason
- CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
- Distribution
- Product was distributed to 30 wholesalers/distributors who may have further distributed the product nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0054-2025, D-0052-2025, D-0053-2025
- Ramipril Capsules USP 10 mg, a) 90 count (NDC 68180-591-09), b) 100 count NDC 68180-591-01), and c) 500 count (NDC 68180-591-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured
- Ramipril Capsules USP 2.5 mg, a) 90 count (NDC 68180-589-09), b) 100 count NDC 68180-589-01), and c) 500 count (NDC 68180-589-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufacture
- Ramipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC 68180-590-01), and c) 500 count (NDC 68180-590-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured
Terminated Class II Drugs
- Recall started
- 21 August 2024
- Terminated
- 29 April 2025
- Reason
- Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
- Distribution
- USA nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0648-2024
- Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-405-01
Terminated Class II Drugs
- Recall started
- 30 May 2024
- Terminated
- 29 April 2025
- Reason
- Failed Content Uniformity Specifications
- Distribution
- Nationwide in the US
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0559-2024
- Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size), Powder for oral suspension, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore Maryland, Manufactured by: Lupin Limited, Mandideep, India NDC
Terminated Class II Drugs
- Recall started
- 8 May 2024
- Terminated
- 29 April 2025
- Reason
- Defective container: lack of seal integrity.
- Distribution
- USA Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0518-2024
- Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, Manufactured by: Lupin Limited, Mandideep, 462 046 India, NDC 68180-
Terminated Class II Drugs
- Recall started
- 24 April 2024
- Terminated
- 29 April 2025
- Reason
- Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
- Distribution
- USA nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0496-2024, D-0497-2024
- Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Man
- Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Man
Terminated Class II Drugs
- Recall started
- 21 March 2024
- Terminated
- 4 April 2025
- Reason
- Subpotent Drug
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0437-2024
- Rifampin Capsules USP, 300mg, 30-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad 431 210 India, NDC 6818-0659-06
Terminated Class II Drugs
- Recall started
- 5 February 2024
- Terminated
- 27 December 2024
- Reason
- Labeling: Incorrect or Missing Package Insert
- Distribution
- OH, IL, NJ
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0337-2024
- Voriconazole for Oral Suspension, 40mg/mL, Orange-Flavored, 49g/75mL when reconstituted. Mixing Directions: Tap the bottle to release the powder. Add 50mL of water to the bottle and shake vigorously for 1 minute. Manufac
Terminated Class II Drugs
- Recall started
- 5 January 2024
- Terminated
- 27 August 2024
- Reason
- Subpotent Drug and Failed Impurities/Degradation Specifications
- Distribution
- Product was distributed to 32 Wholesale/distributor accounts who further distributed the product to 156 distribution sites.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0283-2024, D-0284-2024
- Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Aurangabad 431 210 INDIA, NDC 68180-658-06
- Rifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Aurangabad 431 210 INDIA, NDC 68180-659-06
Terminated Class II Drugs
- Recall started
- 3 January 2024
- Terminated
- 27 December 2024
- Reason
- Failed Impurities/Degradation Specifications
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0274-2024
- Cefixime for Oral Suspension 100mg/5mL, 50 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by:Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-405-01
Terminated Class II Drugs
- Recall started
- 20 December 2023
- Terminated
- 4 April 2025
- Reason
- CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.
- Distribution
- Product was distributed nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0221-2024
- Desloratadine Tablets USP 5mg a) 100 count (NDC 68180-153-01) and b) 500 count (NDC 68180-153-02) bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202.
Terminated Class II Drugs
- Recall started
- 22 November 2023
- Terminated
- 8 July 2024
- Reason
- Failed Dissolution Specifications
- Distribution
- Product was distributed to 3 wholesale/distributor accounts.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0148-2024
- Penicillamine Tablets USP 250 mg, 100-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 Manufactured by: Lupin Limited, Nagpur-441 108, India, NDC# 70748-153-01
Terminated Class III Drugs
- Recall started
- 27 June 2023
- Terminated
- 12 March 2024
- Reason
- Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
- Distribution
- Product was distributed directly to three distributors in TN and NJ. Product may have been further distributed throughout the United States.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0899-2023
- Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 U.S, Manufactured by: Lupin Limited, Aurangabad 431 210 India, NDC 68180-721-03
Terminated Class I Drugs
- Recall started
- 23 June 2023
- Terminated
- 28 January 2025
- Reason
- Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test
- Distribution
- USA nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1081-2023
- Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets 0.451 mg), packaged in 1 blister of 28 tablets each (NDC 68180-904-71) further packaged in
Terminated Class III Drugs
- Recall started
- 20 January 2023
- Terminated
- 16 January 2024
- Reason
- Subpotent Drug: Low assay result observed during long-term stability testing.
- Distribution
- USA Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0174-2023
- Clobetasol propionate Cream USP, 0.05%, 45 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC 68180-956-03
Terminated Class II Drugs
- Recall started
- 12 December 2022
- Terminated
- 31 January 2024
- Reason
- Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study.
- Distribution
- Distributed Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0100-2023
- Rifampin Capsules USP, 300 mg, 30-count bottle; Rx Only, Manufactured for: Lupin Pharmaceuticals Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad 431 210 India. NDC 68180-659-06
Terminated Class II Drugs
- Recall started
- 7 December 2022
- Terminated
- 1 August 2024
- Reason
- CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
- Distribution
- Product was distributed by major distribution chains nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0089-2023, D-0088-2023
- Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-558-09
- Quinapril Tablets USP, 40 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-554-09
Terminated Class II Drugs
- Recall started
- 13 September 2022
- Terminated
- 31 January 2024
- Reason
- Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
- Distribution
- Product was distributed to major distributors/wholesalers nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1536-2022
- Lisinopril Tablets USP, 10 mg, 1000-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Nagpur- 441 108, India. NDC 68180-980-03
Terminated Class II Drugs
- Recall started
- 28 July 2022
- Terminated
- 5 October 2023
- Reason
- CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP) impurity.
- Distribution
- Product was distributed nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1343-2022
- Rifampin Capsules, USP, 150 mg, 30 count HDPE bottles, Rx Only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, 21202 NDC: 68180-658-06
Terminated Class II Drugs
- Recall started
- 10 June 2022
- Terminated
- 8 February 2023
- Reason
- Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.
- Distribution
- Product was distributed to 10 wholesalers/distributors and one mail order account who may have further distributed the product nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1150-2022
- Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 by Lupin Limited, Nagpur-441108, India, NDC 68180-169-16
Terminated Class II Drugs
- Recall started
- 27 April 2022
- Terminated
- 13 April 2023
- Reason
- Failed Stability Specification
- Distribution
- Product was distributed nationwide, including Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0875-2022
- GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP with flavor pack NDC# 43386-060-19
Terminated Class II Drugs
- Recall started
- 31 March 2022
- Terminated
- 22 May 2023
- Reason
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Distribution
- Product was distributed nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0840-2022, D-0839-2022, D-0843-2022, D-0842-2022, D-0838-2022, D-0841-2022
- Losartan Potassium Tablets USP, 100 mg, a) 90-count bottles (NDC# 68180-378-03), b) 1000-count bottles (NDC# 68180-378-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc
- Losartan Potassium Tablets USP, 50 mg, a) 90-count bottles (NDC# 68180-377-03), b) 1000-count bottles (NDC# 68180-377-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc.
- Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/12.5 mg a) 30-count bottles (NDC# 68180-216-06) b) 90-count bottles (NDC# 68180-216-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For
- Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg a) 30-count bottles (NDC# 68180-217-06) b) 90-count bottles (NDC# 68180-217-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For:
- Losartan Potassium Tablets USP, 25 mg, a) 90-count bottles (NDC# 68180-376-03), b) 1000-count bottles (NDC# 68180-376-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc.
- Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg a) 30-count bottles (NDC# 68180-215-06) b) 90-count bottles (NDC# 68180-215-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For:
Terminated Class III Drugs
- Recall started
- 29 December 2021
- Terminated
- 23 August 2022
- Reason
- Out-of-specification impurity test result observed at 18-month long term stability time point.
- Distribution
- Product Distributed in NY and OH.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0358-2022
- Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. NDC 43386-432-
Terminated Class III Drugs
- Recall started
- 22 December 2021
- Terminated
- 12 September 2022
- Reason
- Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
- Distribution
- Nationwide in the USA and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0326-2022
- Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-435-01.
Terminated Class III Drugs
- Recall started
- 19 November 2021
- Terminated
- 15 November 2022
- Reason
- Subpotent Drug
- Distribution
- nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0264-2022
- Tydemy (drospirenone, ethinyl estradiol & levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets, 0.451 mg), packaged in cartons containing 3 wallets of 28 Tablets each, Rx Only, Distributed
Terminated Class III Drugs
- Recall started
- 20 October 2021
- Terminated
- 23 August 2022
- Reason
- Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
- Distribution
- Nationwide in the USA and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0091-2022
- Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-435-01.
Terminated Class II Drugs
- Recall started
- 12 October 2021
- Terminated
- 30 January 2023
- Reason
- CGMP Deviations: impurity N-nitrosoirbesartan detected in API
- Distribution
- Product was distributed to major distributors who may have further distributed the product nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0090-2022, D-0087-2022, D-0088-2022, D-0086-2022, D-0089-2022
- Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) 30 count (NDC 68180-414-06) and b) 90 count (NDC 68180-414-09) bottles, Rx only
- Irbesartan Tablets USP, 150 mg a) 30 count (NDC 68180-411-06) and b) 90 count (NDC 68180-411-09) bottles, Rx only
- Irbesartan Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 count NDC# 68180-412-09) bottles, Rx only
- Irbesartan Tablets USP, 75 mg a) 30 count (NDC 68180-410-06) and b) 90 count (NDC 68180-410-09) bottles, Rx only
- Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg a) 30 count (NDC 68180-413-06) and b) 90 count (NDC 68180-413-09) bottles, Rx only
Terminated Class II Drugs
- Recall started
- 8 October 2021
- Terminated
- 13 March 2023
- Reason
- Out of specification result observed in a dissolution test at the 9-month long term stability time point.
- Distribution
- Distributed Nationwide in the USA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0027-2022
- Imipramine Pamoate Capsules 125 mg, 30-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 UNited States. Manufactured by: Lupin Limited, Pithampur, (M.P.) 454 775 India NDC# 68
Terminated Class II Drugs
- Recall started
- 29 April 2021
- Terminated
- 22 February 2022
- Reason
- Subpotent Drug
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0390-2021
- Cefixime for Oral Suspension USP 100 mg/5mL, 50mL HDPE bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc. Baltimore, Maryland, 21202 United States, Manufactured by: Lupin Limited, Manddeep, 462 046, India, ND
Terminated Class II Drugs
- Recall started
- 26 March 2021
- Terminated
- 16 December 2021
- Reason
- Superpotent Drug
- Distribution
- Nationwide in the USA and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0332-2021
- Cefprozil for Oral Suspension USP, 250mg/5mL, packaged as a) 50 mL (when mixed) bottles (NDC 68180-402-01); b) 75 mL (when mixed) bottles (NDC 68180-402-02); and c) 100 mL (when mixed) bottles (NDC 68180-402-03); Rx only
Terminated Class III Drugs
- Recall started
- 21 January 2021
- Terminated
- 16 December 2021
- Reason
- Failed Impurities/Degradation Specifications; Out-of-specification test results observed for Impurity C at 9 month long-term stability time point.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0247-2021
- Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, 60 mL (usable volume after constitution), Rx only, Manufactured for:Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad, Ma
Terminated Class II Drugs
- Recall started
- 21 July 2020
- Terminated
- 21 January 2022
- Reason
- Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test.
- Distribution
- Nationwide within the U.S.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1502-2020
- Mibelas 24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) chewable,1 mg/0.02 mg/75 mg, Rx Only, Provides 24 days of active therapy, Pouch Contains one wallet of 28 tablets, NDC: 681
Terminated Class II Drugs
- Recall started
- 17 July 2020
- Terminated
- 26 August 2021
- Reason
- Presence of Foreign Tablets/Capsules: Lisinopril Tablets USP, 20mg found in a 1000 count bottle of Lisinopril Tablets USP, 10mg
- Distribution
- Product was distributed to OH and may have been further distributed throughout the United States.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1413-2020
- Lisinopril Tablets USP, 10 mg, 1000 count bottles, Manufactured by: Lupin Limited, Nagpur INDIA, For BluePoint Laboratories NDC 68001-334-08
Terminated Class II Drugs
- Recall started
- 7 July 2020
- Terminated
- 23 December 2021
- Reason
- CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
- Distribution
- Product was distributed throughout the United States.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1382-2020, D-1385-2020, D-1384-2020, D-1383-2020
- Metformin Hydrochloride Extended-release Tablets USP 500 mg, 100 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-338-01
- Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 60 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-337-07
- Metformin Hydrochloride Extended-Release Tablets USP 500 mg, 60 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-336-07
- Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 90 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-339-09
Terminated Class II Drugs
- Recall started
- 2 July 2020
- Terminated
- 30 June 2021
- Reason
- Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples.
- Distribution
- U.S.A. Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1406-2020
- Cefdinir for Oral Suspension USP, 250 mg/5mL, packaged in 60 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited, Mandideep, India, NDC 68180-723-20
Terminated Class II Drugs
- Recall started
- 11 June 2020
- Terminated
- 23 December 2021
- Reason
- CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
- Distribution
- Product was distributed throughout the United States.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1334-2020
- Metformin Hydrochloride Extended-release Tablets USP, 500 mg, 60 count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD Manufactured by: Lupin Limited Goa INDIA (NDC 68180-336-07)
Terminated Class II Drugs
- Recall started
- 28 May 2020
- Terminated
- 4 May 2021
- Reason
- Product Mix Up: Lisinopril 10 mg tablets were found in Lisinopril 5 mg 1000-count bottle.
- Distribution
- Nationwide within the US.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1290-2020
- Lisinopril Tablets, USP, 5 mg, Rx Only, 1000-count bottle, Manufactured for: Lupin Pharmaceuticals Inc., Baltimore, MD 21202, Manufactured by: Lupin Limited, Nagpur - 441 108, India, NDC 68180-513-03.
Terminated Class II Drugs
- Recall started
- 20 April 2020
- Terminated
- 7 June 2021
- Reason
- Product Mix-Up: a complaint received indicating mix-up of 10 mg Lisinopril tablets inside of 2 sealed bottles of 20 mg/1000 count bottles.
- Distribution
- Product was distributed Nationwide in the United States.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1250-2020
- Lisinopril Tablets USP, 20 mg, 1000-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore MD 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, India. NDC 68180-0981-03
Terminated Class II Drugs
- Recall started
- 15 April 2020
- Terminated
- 7 June 2021
- Reason
- Subpotent Drug: low out of specification (OOS) test result observed in long term stability study.
- Distribution
- Nationwide with the United States and Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1252-2020
- Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Mandideep 462 046 INDIA, NDC 68180-405-01
Terminated Class II Drugs
- Recall started
- 1 April 2020
- Terminated
- 30 June 2021
- Reason
- Presence of Foreign Tablet/ Capsule: Product complaint received indicating mix-up of one lisinopril 5mg tablet inside of a 30 mg, 100-count bottle of Lisinopril Tablets.
- Distribution
- U.S.A. Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1079-2020
- Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, NDC 68180-982-01
Terminated Class II, Class III Drugs
- Recall started
- 9 March 2020
- Terminated
- 25 May 2021
- Reason
- Failed Content Uniformity Specifications: Out Of Specification test results observed for content uniformity.
- Distribution
- Nationwide in the USA and Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1056-2020, D-1055-2020
- Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.05mg/0.03 mg, 0.075mg/0.04mg, and 0.125mg/0.03mg, packaged in 1 Wallet of 28 Tablets (NDC 68180-857-11), 3 Wallets of 28 Tablets Each per carton (NDC 68180-857-13); Rx
- Bekyree (desogestrel and ethinyl estradiol tablets USP, 0.15 mg/0.02 mg and ethinyl estradiol tablets USP, 0.01 mg), packaged in 1 Wallet of 28 Tablets (NDC 68180-879-11), 3 Wallets of 28 Tablets Each per carton (NDC 681
Terminated Class II Drugs
- Recall started
- 19 February 2020
- Terminated
- 3 June 2021
- Reason
- Failed Impurities/Degradation Specification; high out of specification results observed
- Distribution
- Product was distributed throughout the United States.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0866-2020
- Desoximetasone Topical Spray, 0.25%, 2.5 mg desoximetasone, 100 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Baltimore, MD
Terminated Class II Drugs
- Recall started
- 12 February 2020
- Terminated
- 3 June 2021
- Reason
- Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study.
- Distribution
- Nationwide within the United States.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0855-2020
- Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States. Manufactured by: Lupin Limited Pithampur (M.P.)-
Terminated Class III Drugs
- Recall started
- 10 January 2020
- Terminated
- 3 June 2021
- Reason
- CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data.
- Distribution
- Distributed nationwide in the US
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0790-2020
- Tri-Lo-Marzia (Norgestimate and Ethinyl Estradiol Tablets, USP), 0.180 mg/0.025 mg; 0.215mg/0.025 mg and 0.250 mg/0.025 mg, Pack size - 3 x 28's wallets/carton, Rx Only, Distributed by Lupin Pharmaceuticals, Inc, Baltimo
Terminated Class II Drugs
- Recall started
- 26 December 2019
- Terminated
- 22 October 2020
- Reason
- Failed Tablet/Capsule Specifications: Complaints related to crumbling of tablets when popped out of the blister pack.
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0638-2020
- Blisovi Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets USP and ferrous fumarate tablets 75mg), Rx Only, Distributed by: Lupin Pharmaceuticals Inc Baltimore, MD 21202, Manufactured for: Lupin Limited Pith
Terminated Class III Drugs
- Recall started
- 13 December 2019
- Terminated
- 19 October 2020
- Reason
- Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other individual impurity.
- Distribution
- Nationwide in the U.S.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0635-2020
- Bimatoprost Ophthalmic Solution, 0.03%, For Use in the Eyes Only, Sterile, Rx Only, 7.5 mL bottle, Manufactured by: Lupin Limited, Pithampur (M.P.), INDIA, NDC: 68180-429-03.
Terminated Class III Drugs
- Recall started
- 10 December 2019
- Terminated
- 29 April 2021
- Reason
- Failed Dissolution Specifications: High out of specification result observed at stability studies.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0629-2020
- Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in a) 90-count bottles (NDC 68180-249-09 and b) 500-count bottles (NDC 68180-249-02); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, M
Terminated Class III Drugs
- Recall started
- 1 November 2019
- Terminated
- 4 March 2021
- Reason
- Presence of Foreign substance: identified as a dead ant.
- Distribution
- Product was distributed to major distributors/wholesalers throughout the United States.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0305-2020, D-0306-2020, D-0304-2020
- Cefdinir for Oral Suspension USP, 250 mg/5mL,100 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 6
- Cefdinir for Oral Suspension USP, 125 mg/5mL, packaged in a) 60 mL bottle (NDC 68180-722-20), b) 100 mL bottle (NDC 68180-722-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United
- Cephalexin for Oral Suspension USP, 250 mg/5mL, 200 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mu
Terminated Class II Drugs
- Recall started
- 19 July 2019
- Terminated
- 9 September 2020
- Reason
- Presence of Foreign Tablets/Capsules: Product complaint received of one Fenofibrate tablet 145mg observed in 500 s count product bottle.
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1581-2019
- Lisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg, 500-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775,
Terminated Class II Drugs
- Recall started
- 17 July 2019
- Terminated
- 14 September 2020
- Reason
- Presence of Foreign Substance; Product complaints received related to brownish/blackish stains on the tablets and brownish/blackish powder observed inside the bottles.
- Distribution
- Product was distributed to wholesalers/distributors and supermarket and drug chains throughout the United States.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1720-2019
- Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 100 tablet bottle, Rx only, Manufactured by for: Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by: Lupin Limited, Pithampur, INDIA NDC 68180-518-0
Terminated Class III Drugs
- Recall started
- 17 July 2019
- Terminated
- 14 September 2020
- Reason
- Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of containers test at 9 month long term stability condition for upright orientation.
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1518-2019
- Nystatin and Triamcinolone Acetonide Cream USP100,000 units/g, 0.1%, 15 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 IN
Terminated Class III Drugs
- Recall started
- 11 July 2019
- Terminated
- 9 September 2020
- Reason
- Labeling: Missing label; Product complaints reported missing bottle label.
- Distribution
- Nationwide in the U.S. and PR.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1490-2019
- Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL Bottle, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Pi
Terminated Class II Drugs
- Recall started
- 2 July 2019
- Terminated
- 16 February 2021
- Reason
- Failed Impurities/Degradation Specifications: Kaitlib Fe Tablets has an out of specification result observed in long term stability study.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1565-2019
- Kaitlib Fe norethindrone and ethinyl estradiol chewable tablets (0.8 mg/0.025 mg) and Ferrous Fumarate, Chewable Tablets, Rx Only, Distributed by: Lupin Pharmaceuticals, Inc. Baltimore, MD - 21202 Manufactured by: Lupin
Terminated Class II Drugs
- Recall started
- 23 May 2019
- Terminated
- 22 October 2020
- Reason
- Complaint received of metal piece identified in the product bottle prior to the reconstitution.
- Distribution
- Distributed Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1320-2019
- Cefdinir for Oral Suspension USP, 250mg/5mL, Powder for oral suspension, 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 20201, Manufactured by: Lupin Limited, Mandideep 462 046
Terminated Class III Drugs
- Recall started
- 1 April 2019
- Terminated
- 1 July 2020
- Reason
- Failed Impurities/Degradation Specifications; 18 month long term stability study.
- Distribution
- Product was distributed to 6 wholesalers/ drug chains and 2 mail order pharmacies that may have further distribute the product throughout the United States.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1121-2019
- Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablet bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by : Lupin Limited, Goa, INDIA -- NDC 68180-198-06
Terminated Class II Drugs
- Recall started
- 22 March 2019
- Terminated
- 1 July 2020
- Reason
- Failed Impurities/Degradation Specifications: Out-of-specification results observed in related substance test (Any Other Individual Impurity and Total impurities) in Ethinyl Estradiol Tablets USP 0.01mg at 12 month long term stability study.
- Distribution
- Nationwide in the USA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1057-2019
- Fayosim (levonorgestrel and ethinyl estradiol) tablets USP, (0.15 mg/0.02 mg, 0.15 mg/0.025 mg, 0.15 mg/0.03 mg) and ethinyl estradiol tablets USP, (0.01 mg), packaged in 1 Extended-Cycle Wallet of 91 Tablets packed in a
Terminated Class III Drugs
- Recall started
- 13 March 2019
- Terminated
- 26 June 2020
- Reason
- Defective Container: Repetitive complaints received indicating pump not working.
- Distribution
- Recalled product was distributed to 7 major wholesale/drug chain distributors and 1 supermarket chain that may have further distribute the product throughout the United States.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1010-2019
- Testosterone Topical Solution, 30mg/1.5mL, 110mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 INDIA, NDC
Terminated Class III Drugs
- Recall started
- 26 February 2019
- Terminated
- 22 June 2020
- Reason
- Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due to high out-of-specification for impurities.
- Distribution
- Nationwide in the USA and Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0517-2019
- Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-422-01.
Terminated Class III Drugs
- Recall started
- 13 February 2019
- Terminated
- 6 October 2020
- Reason
- CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
- Distribution
- Nationwide in the USA and Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0513-2019
- Lovastatin Tablets USP, 40 mg, packaged in a) 60-count (NDC 68180-469-07 and b) 100-count (NDC 68180-469-01) bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lu
Terminated Class III Drugs
- Recall started
- 1 February 2019
- Terminated
- 26 June 2020
- Reason
- Failed Impurities/Degradation Specifications: Out of specification test results in related substance at three-month long term stability study was obtained.
- Distribution
- Product was distributed by 5 wholesalers, 6 drug chains, 4 mail order pharmacies and 1 mail order pharmacy/supermarket who may have further distribute the product throughout the United States.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0484-2019
- Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL dropper bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 Manufactured by: lupin Limited Pithampur (M.P.) 454 775 India. NDC 68180-4
Terminated Class III Drugs
- Recall started
- 28 January 2019
- Terminated
- 22 June 2020
- Reason
- Failed Impurities/Degradation Specifications: OOS results observed in any other individual impurity and total impurities.
- Distribution
- Nationwide within the United States.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0429-2019
- Bimatoprost Ophthalmic Solution 0.03%, packaged in a) 5 mL (NDC 68180-429-02) and b) 7.5 mL (NDC 68180-429-03) bottles, Rx only, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA.
Terminated Class II Drugs
- Recall started
- 9 January 2019
- Terminated
- 8 April 2020
- Reason
- CGMP Deviations; presence of extraneous material in the was observed in area that is between the primary package that is heat sealed and secondary packaging (poly-woven bag) of sucrose (an excipient) used in the finished product.
- Distribution
- Product was distributed to 5 wholesalers, 2 drug chains and 1 supermarket who may have further distributed the product throughout the United States.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0423-2019
- Cephalexin for Oral Suspension USP 250mg/5 mL, Rx Only Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited Mandideep 462 046 India --- NDC 68180-441-01
Terminated Class II Drugs
- Recall started
- 7 January 2019
- Terminated
- 8 July 2020
- Reason
- CGMP Deviation; manufacturing batch record could not be located
- Distribution
- Product was distributed to 12 major distributors who may have further distributed the product throughout the United States.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0380-2019
- Cephalexin for Oral Suspension USP, 250mg/5mL, 200 mL (when mixed), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited, Mandideep, India ---- NDC 68180-0124-02
Terminated Class II Drugs
- Recall started
- 2 January 2019
- Terminated
- 26 June 2020
- Reason
- CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0375-2019, D-0376-2019
- Cefdinir for Oral Suspension USP, 125mg/5mL, packaged in a) 60mL (NDC 68180-722-20), b)100mL (NDC 68180-722-10), Rx Only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202; Manufactured by: Lupin Limited M
- Cefdinir for Oral Suspension USP, 250mg/5mL, packaged in a) 60mL (NDC 68180-723-20), b)100mL (NDC 68180-723-10), Rx Only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202; Manufactured by: Lupin Limited M
Terminated Class I Drugs
- Recall started
- 20 December 2018
- Terminated
- 18 August 2020
- Reason
- Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
- Distribution
- Nationwide in the USA and Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0355-2019, D-0356-2019, D-0357-2019, D-0358-2019
- Ceftriaxone for Injection USP, 250 mg, packaged in a) one Single Use Vial (NDC 68180-611-01) and b) 10 Single Use Vials per box (NDC 68180-611-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calver
- Ceftriaxone for Injection USP, 500 mg, packaged in a) one Single Use Vial (NDC 68180-622-01) and b) 10 Single Use Vials per box (NDC 68180-622-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calver
- Ceftriaxone for Injection USP, 1 g, packaged in a) one Single Use Vial (NDC 68180-633-01) and b) 10 Single Use Vials per box (NDC 68180-633-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert S
- Ceftriaxone for Injection USP, 2 g, packaged in 10 Single Use Vials (NDC 68180-644-01) per box, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured b
Terminated Class III Drugs
- Recall started
- 9 October 2018
- Terminated
- 16 December 2019
- Reason
- Defective Container: Repetitive complaints received indicating pump not working.
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0087-2019
- Testosterone Topical Solution, 30mg/1.5mL, 110mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 INDIA, NDC
Terminated Class II Drugs
- Recall started
- 13 August 2018
- Terminated
- 15 October 2019
- Reason
- Presence of Foreign Substance: Product complaint was received of metal contaminant observed in one tablet.
- Distribution
- Product was distributed to distributors, mail order pharmacy and supermarkets throughout the United States.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1077-2018
- Lisinopril Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202, NDC 68180-980-03
Terminated Class III Drugs
- Recall started
- 26 July 2018
- Terminated
- 6 December 2019
- Reason
- Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study.
- Distribution
- Product was distributed throughout the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1050-2018
- Moxifloxacin Ophthalmic Solution USP, 0.5%, 5 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA, NDC
Terminated Class II Drugs
- Recall started
- 17 May 2018
- Terminated
- 1 May 2019
- Reason
- Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0837-2018, D-0838-2018
- My Way (Levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per carton, GAVIS Pharmaceuticals, A Lupin Group Company; Mfg. for Lupin Pharmaceuticals, Inc., Baltimore
- My Way (levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per carton, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Lupin L
Terminated Class II Drugs
- Recall started
- 27 March 2018
- Terminated
- 15 April 2019
- Reason
- Superpotent Drug
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0684-2018
- Lupin Cefdinir powder for Oral Suspension USP, 250 mg/5 mL in (a) 60 mL packs ( NDC 68180-723-20) and (b) 100 mL packs ( 68180-723-10), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202
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.