New York, NY, United States
Pfizer Inc. recalls
47 recalls recorded since 2018, most recently on 4 September 2026. 11 are listed as ongoing. Status and classification are as published by the FDA.
Recalls47
Ongoing (FDA)11
Terminated or completed36
Class I (FDA)10
Ongoing Class II Drugs
- Recall started
- 4 September 2026
- Reason
- Lack of Assurance of Sterility
- Distribution
- US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0853-2026
- Dopamine HCl Inj., USP, 200 mg/5 mL (40 mg/mL), 5 mL Single-dose, 25 vials per tray, Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, Vial NDC 0409-5820-11, Carton NDC 0409-5820-01.
Ongoing Class II Drugs
- Recall started
- 4 August 2025
- Reason
- Lack of Assurance of Sterility.
- Distribution
- U.S. Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0590-2025, D-0591-2025
- Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045, USA. NDC 0409-4933-05. Case: NDC 0409-4933-10.
- Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-6637-24. Case NDC: 00409-6637-14.
Ongoing Class II Drugs
- Recall started
- 29 July 2025
- Reason
- Subpotent drug
- Distribution
- Within U.S
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0575-2025
- Levoxyl (levothyroxine sodium tablets, USP), 50 mcg, 100-count bottle, Rx only, Distributed by: Pfizer Inc., New York, NY 10017, Made in Austria, NDC 60793-851-01.
Ongoing Class II Drugs
- Recall started
- 10 July 2025
- Reason
- CGMP Deviations; particulates identified during visual inspection
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0544-2025, D-0545-2025
- Bicillin L-A (penicllin G benzathine injectable suspension), 1,200,000 units per 2 mL, 2 mL-vial, Rx Only, Distributed by Pfizer Inc., New York, NY 10001. Made in Austria, Carton NDC - 60793-701-10, Syringe NDC - 60793-
- Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units per 4 mL, 4ml-vial, Rx Only, Distributed by Pfizer Inc., New York, NY 10001, Made in Austria, Carton NDC- 60793-702-10 , Syringe NDC-60793-702
Ongoing Class II Drugs
- Recall started
- 28 May 2025
- Reason
- Discoloration; discolored solution from cracked vials
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0489-2025
- DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose Vial, carton of 10 Fliptop Vials, Rx only, For Intravenous Use Only, Made in Italy, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. ND
Ongoing Class II Drugs
- Recall started
- 20 May 2024
- Reason
- Lack of Assurance of Sterility-The potential for incomplete crimp seals.
- Distribution
- US Nationwide and Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0565-2024, D-0564-2024
- Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intravenous Injection Only, Rx Only, Distributed by Hospira, Inc., Lake Forest, IL 6004
- Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intramuscular or Intravenous Use, Rx Only, Distributed by Hospira, Inc., Lake Forest, IL 60045
Ongoing Class I Drugs
- Recall started
- 21 December 2023
- Reason
- Presence of Particulate Matter; identified as glass
- Distribution
- Nationwide in the USA and Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0233-2024, D-0234-2024, D-0235-2024
- 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5 mEq/mL), Glass ABBOJECT Unit of Use Syringe, For Intravenous Use, Rx Only, 10 mL Syringe per Carton, Hospira, Inc., Lake Forst, IL 60045, NDC 0409-5534-24 (carton),
- 8.4 % Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), Lifeshield, Glass ABBOJECT Unit of Use Syringe, Rx Only, 50 mL Syringe per Carton, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6637-24 (carton), 0409-66
- Atropine Sulfate Injection, USP 1 mg/10 mL (0.1 mg/mL), Lifeshield, Glass ABBOJECT Unit of Use Syringe, Rx Only, 10 mL Syringe per Carton, Hospira, Inc., Lake FOrest, IL 60045, NDC 0409-4911-11 (carton), 0409-4911-34 (ca
Ongoing Class I Drugs
- Recall started
- 21 December 2023
- Reason
- Presence of particulate matter: glass
- Distribution
- Nationwide in the USA, Netherlands and Libya
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0261-2024
- Bleomycin for Injection, USP, 15 units per vial, 1 single dose glass fliptop vial, Rx Only, Distributed by: Hospira, Inc., Lake Forest, IL 68045, NDC 61703-332-18
Terminated Class I Drugs
- Recall started
- 2 October 2023
- Terminated
- 14 February 2025
- Reason
- Presence of Particulate Matter: identified as glass.
- Distribution
- Nationwide in the US and Puerto Rico. The products were not distributed to government accounts or foreign consignees.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0102-2024, D-0100-2024, D-0101-2024
- 2% Lidocaine HCl Injection, USP, 100mg/5mL(20mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Distributed by Hospira Inc., Lake Forest, IL 60045, NDC 0409-4903-11
- 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-5534-24
- 1% Lidocaine HCl Injection, USP, 50mg/5mL(10mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Distributed by Hospira Inc., Lake Forest, IL 60045, NDC 0409-4904-11
Ongoing Class III Drugs
- Recall started
- 8 March 2023
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date: The carton and bottle labels state an expiry date of March 2026; the correct expiration date is February 2025.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0532-2023
- MEKTOVI (binimetinib) tablets, 15 mg, 180-count bottle, Rx only, Distributed by: Array BioPharma Inc., a wholly owned subsidiary of Pfizer Inc., Boulder, CO 80301. NDC: 70255-010-02
Completed Class II Drugs
- Recall started
- 29 December 2022
- Reason
- Lack of assurance of sterility: Bags have the potential to leak.
- Distribution
- Nationwide in the USA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0097-2023
- Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium Chloride Injection, 1,000 mL bags, a) Case (NDC 0409-7620-59), b) Single Unit (NDC 0409-7620-49), Rx only, Distributed By Hospira, Inc., Lake
Terminated Class I Drugs
- Recall started
- 22 December 2022
- Terminated
- 7 August 2024
- Reason
- Presence of Particulate Matter: Glass particulate matter detected in injectable.
- Distribution
- USA nationwide and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0184-2023
- Vancomycin Hydrochloride for Injection, USP, 1.5 g/vial, Sterile powder, Single-dose Fliptop Vial, 10 vials per carton, Rx only, Distributed by: Hospira, Inc., Lake Forest, IL 60045. NDC Vial 0409-3515-11; NDC Carton 0
Terminated Class II Drugs
- Recall started
- 27 September 2022
- Terminated
- 21 August 2024
- Reason
- Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial.
- Distribution
- Distributed in the United States and Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0003-2023
- Aminophylline Injection, USP 250 mg/10 mL (25 mg/mL) 25x10 mL Single-dose vial, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045 USA. NDC 0409-5921-16 (vial) 0409-5921-01 (carton)
Terminated Class I Drugs
- Recall started
- 22 August 2022
- Terminated
- 30 June 2025
- Reason
- Presence of particulate matter
- Distribution
- USA Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1540-2022
- PROPOFOL Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL glass fliptop vial (NDC 0409-4699-54) further packaged in a tray of 10 vials (NDC Carton: 0409-4699-24), Rx only, Distributed by Hospira, Inc., Lake
Terminated Class I Drugs
- Recall started
- 13 July 2022
- Terminated
- 13 May 2024
- Reason
- Presence of particulate matter: particulate identified as a beetle.
- Distribution
- USA Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1301-2022
- Propofol Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL per glass fliptop vial (NDC 0409-4699-54) further packaged in a tray of 10 vials (NDC Carton: 0409-4699-24), Rx only, Distributed by Hospira, Inc.,
Terminated Class II Drugs
- Recall started
- 22 April 2022
- Terminated
- 5 October 2023
- Reason
- CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
- Distribution
- Nationwide and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0872-2022, D-0873-2022, D-0874-2022
- Accupril (Quinapril HCl Tablets) 10 mg, 90 Tablets Rx only NDC 0071-0530-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017
- Accupril (Quinapril HCl Tablets) 20 mg, 90 Tablets, Rx only NDC 0071-0532-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017
- Accupril (Quinapril HCl Tablets) 40 mg, 90 Tablets, Rx only NDC 0071-0535-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017
Terminated Class II Drugs
- Recall started
- 21 March 2022
- Terminated
- 28 August 2024
- Reason
- CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0758-2022, D-0759-2022, D-0761-2022, D-0754-2022, D-0760-2022, D-0757-2022, D-0756-2022, D-0755-2022
- quinapril and hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets bottles, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977, Made in Germany, NDC 59762-5225-9
- quinapril HCl/hydrochlorothiazide tablets, 20 mg/12.5 mg*, 90 Tablets bottles, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977, Made in Germany, NDC 59762-0220-1
- Accuretic (quinapril HCl/hydrochlorothiazide) tablets, 20 mg/12.5 mg*, 90 Tablets, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY. NY 10017, Made in Germany, NDC 0071-5212-23 .
- Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 10 mg/12.5 mg*, 90 Tablets bottles, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-3112-23.
- quinapril HCl/hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977, Made in Germany, NDC 59762-0223-1
- Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/25 mg, 90 tablets bottles, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-0223-23.
- Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/12.5 mg, 90 tablets bottles, Rx Only Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-0220-23.
- Accuretic (quinapril HCl/hydrochlorothiazide) Tablets 10 mg/12.5 mg 90 tablets bottle, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-0222-23
Terminated Class II Drugs
- Recall started
- 30 November 2021
- Terminated
- 12 July 2023
- Reason
- Lack of sterility assurance: bag has the potential to leak.
- Distribution
- USA Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0265-2022
- 5% Dextrose Injection, USP, 50 mL ADD-Vantage Unit, Rx only, Distributed by Hospira, INC., Lake Forest, IL 60045 USA, NDC 0409-7100-68/0409-7100-66
Ongoing Class II Drugs
- Recall started
- 13 August 2021
- Reason
- CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0809-2021, D-0811-2021, D-0808-2021, D-0810-2021
- Chantix (varenicline) tablets 0.5mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 0069-0468-56.
- Chantix (varenicline) tablets 1 mg, Carton containing 4 blister packs of 14 tablets each,, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 0069-0469-03. EXPIRATION DATE:
- Chantix (varenicline) tablets 0.5mg/1mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 00069-0471-03. carton containing one blister pack of 11 0.5 mg tablet
- Chantix (varenicline) tablets 1 mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 0069-0469-56.
Ongoing Class II Drugs
- Recall started
- 9 June 2021
- Reason
- CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0699-2021, D-0701-2021, D-0700-2021
- Chantix (varenicline) tablets, 0.5mg*, 56 Tablets, Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc., NY, NY 10017, Made in Ireland. NDC 0069-0468-56
- Chantix (varenicline) tablets, 1 mg, 56 Tablets, Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc., NY, NY 10017, Made in Ireland. NDC 0069-0469-56
- Chantix (varenicline)Tablets, Contains: 1 Starting Week (0.5 mg* x 11 tablets), 3 Continuing Weeks (1 mg x 42 tablets), Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017, Made in Ireland, NDC 006
Terminated Class I Drugs
- Recall started
- 3 May 2021
- Terminated
- 4 April 2023
- Reason
- Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP
- Distribution
- Nationwide in the USA, Puerto Rico, and Guam
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0626-2021, D-0627-2021
- 0.5% Bupivacaine Hydrochloride Injection, USP, 150 mg/30 mL (5 mg/mL), 30 mL Single-dose Teartop Vials (NDC 0409-1162-19), packaged in 25 vials per tray (NDC 0409-1162-02), Rx only, Distributed by Hospira, Inc., Lake For
- 1% Lidocaine HCl Injection, USP, 300 mg/30 mL (10 mg/mL), 30 mL Single-dose vial (NDC 0409-4279-16), packaged in 25 vials per tray (NDC 0409-4279-02), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA.
Terminated Class II Drugs
- Recall started
- 3 May 2021
- Terminated
- 29 July 2023
- Reason
- Presence of Particulate Matter: particulate matter identified as an insect in one vial.
- Distribution
- Nationwide USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0384-2021
- Sterile Water for Inj., USP, 25 x 100 mL Single Dose Vials per carton, Rx only, For Drug Diluent Use Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, NDC Carton: 0409-4887-99; NDC Vial: 0409-4887-25
Terminated Class II Drugs
- Recall started
- 20 July 2020
- Terminated
- 8 December 2022
- Reason
- Lack of Assurance of Sterility; potential loose metal overseal crimp defects.
- Distribution
- United States including Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1446-2020
- Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL) 2 mL Single-dose Fliptop Vials, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045 USA NDC 0409-9094-12
Terminated Class II Drugs
- Recall started
- 29 May 2020
- Terminated
- 13 January 2022
- Reason
- Presence of Particulate Matter: particulate matter identified after reconstitution.
- Distribution
- Distributed Nationwide in the US
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1306-2020
- Unasyn (ampicillin sodium/sulbacatam) for injection, 1.5 g* per vial, Rx Only, 10 vials/carton, Made in Italy Distributed by Roerig Division of Pfizer Inc. New York, NY 10017 vial NDC 0049-0013-81, carton NDC 0049-0013-8
Terminated Class III Drugs
- Recall started
- 27 May 2020
- Terminated
- 30 June 2023
- Reason
- Failed Dissolution Specifications
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1342-2020
- Duavee (conjugated estrogens/bazedoxifene) tablets 0.45/20 mg, packaged in 2 blister cards containing 15 tablets each (30 tablets), Rx Only, Distributed by Wyeth Pharmaceuticals LLC A subsidiary of Pfizer In Philadelphia
Terminated Class II Drugs
- Recall started
- 27 February 2020
- Terminated
- 28 December 2022
- Reason
- Lack of Assurance of Sterility--Reports of loose metal ferrule crimps on vials for injection. The entire cap either lifted or dislodged while attempting to flip off the orange color plastic button.
- Distribution
- Nationwide within the United States and Albania, Israel, Serbia, Macedonia, Afghanistan, Botswana/South Africa/Zimbabwe, India, Israel, Rwanda, Uruguay, Mongolia
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0995-2020
- Elelyso (taliglucerase alfa) for injection, 200 units/vials,, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017. NDC 0069-0106-01
Terminated Class II Drugs
- Recall started
- 5 February 2020
- Terminated
- 8 March 2021
- Reason
- Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection.
- Distribution
- Nationwide in the USA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0841-2020, D-0842-2020
- Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/20 mg*, 30-count bottle, Rx only, Distributed by: Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Germany, NDC 0069-2180-30.
- Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/10 mg*, 30-count bottle, Rx only, Distributed by: Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Germany, NDC 0069-2160-30.
Terminated Class II Drugs
- Recall started
- 3 February 2020
- Terminated
- 29 September 2022
- Reason
- Defective Container: confirmed customer reports for vials with loose metal overseal crimp defects, which may result in lack of assurance of sterility.
- Distribution
- Nationwide in the U.S. and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0835-2020
- Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL), 2 mL Single-dose Vial, Each Tray contains 25 Vials, Intravenous or Intramuscular Use, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045, NDC 00409-9
Terminated Class II Drugs
- Recall started
- 27 November 2019
- Terminated
- 14 January 2022
- Reason
- Labeling: Incorrect or Missing Lot and/or expiration date.
- Distribution
- Nationwide within the United States including Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0577-2020
- 25% Dextrose Injection, USP 2.5 grams (250 mg/mL) 10 mL Single-dose, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-1775-10
Terminated Class II Drugs
- Recall started
- 2 October 2019
- Terminated
- 1 December 2020
- Reason
- Lack of Assurance of Sterility: Bag has the potential to leak.
- Distribution
- Nationwide in the United States and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0136-2020
- 10% LMD in 5% Dextrose Injection Dextran 40 in Dextrose Injection, USP, 500 mL bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7418-13
Terminated Class III Drugs
- Recall started
- 12 September 2019
- Terminated
- 10 April 2023
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0002-2020, D-0001-2020
- Zarontin (ethosuximide capsules, USP) 250 mg, 100-count bottle, Rx Onl,y Made in Netherlands Distributed by Parke-Davis Division of Pfizer In NY, NY 10017, NDC 0071-0237-24
- ethosuximide capsules, USP, 250 mg, 100-count bottle, Rx Only, Distributed by: Greenstone LLC Peapack, NJ 07977 Made in Netherlands. NDC 59762-2250-2
Terminated Class II Drugs
- Recall started
- 6 September 2019
- Terminated
- 25 March 2023
- Reason
- Lack of Assurance of Sterility
- Distribution
- Nationwide US and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1852-2019
- Bacteriostatic Water for Injection, USP, 30 mL vials, Rx only, Mfd. for: Hospira, Inc., Lake Forest, IL 60045 USA. NDC Vial: 0409-3977-01; NDC Carton: 0409-3977-03
Terminated Class II Drugs
- Recall started
- 14 August 2019
- Terminated
- 20 June 2023
- Reason
- Microbial Contamination of Non-Sterile Products: contamination with Burkholderia and Pseudomonas.
- Distribution
- Nationwide in the USA and Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1845-2019
- RELPAX (eletriptan HBr) tablets, 40 mg, packaged in a) 6-count (1 card x 6 tablets) per carton, NDC 0049-2340-45; b) 12-count (2 cards x 6 tablets) per carton, NDC 0049-2340-05, Rx only, Made in Ireland, Distributed by P
Terminated Class II Drugs
- Recall started
- 9 July 2019
- Terminated
- 27 October 2021
- Reason
- Lack of Assurance of Sterility: Bags have the potential to leak.
- Distribution
- United States, PR, and Guam
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1487-2019, D-1486-2019
- Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection, 20 mg/100 mL, 100 mL bag, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-2776-23, Barcode (01)00304092776233.
- Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection 40 mg/200 mL, 200 mL bag, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-2776-02, Barcode (01)00304092776028.
Terminated Class III Drugs
- Recall started
- 29 April 2019
- Terminated
- 26 April 2021
- Reason
- Labeling: Label Error on Declared Strength: an artwork error on the secondary packaging of Relpax 40 mg Tablets, indicates that each tablet contains eletriptan hydrobromide equivalent to 20mg eletriptan, instead of 40mg, on one side of the carton.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1278-2019
- Relpax (eletriptan HBr) 40 mg, a) 12 tablets 2 cards x six 40 mg tablets per blister pack, NDC 0049-2340-05; b) 6 tablets 1 card x six 40 mg tablets per blister pack, NDC 0049-2340-45, Rx Only, Made in Ireland, Distribut
Terminated Class III Drugs
- Recall started
- 15 March 2019
- Terminated
- 11 August 2022
- Reason
- Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
- Distribution
- Nationwide USA and Guam
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1069-2019, D-1071-2019, D-1072-2019, D-1070-2019, D-1068-2019, D-1067-2019
- Cleocin Phosphate, clindamycin injection, USP, 900 mg/ 6 mL (150 mg/mL), 6 mL vial, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Pfizer, Inc, New York, NY 10017. NDC 0009-3447-01
- Clindamycin Injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vials, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA, NDC 47781-620-94
- Clindamycin Injection, USP, 900 mg/6 mL (150 mg/mL), 6 mL vial, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA. NDC 47781-621-94
- Clindamycin Injection, USP, 300 mg/ 2 mL (150 mg/mL), 2 mL vials, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA.,NDC 47781-619-94
- Cleocin Phosphate, clindamycin injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vial, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Pfizer, Inc, New York, NY 10017, NDC 0009-3124-01
- Cleocin Phosphate (clindamycin injection), USP, 300 mg/ 2 mL (150 mg/mL), 2 mL-vial, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Pfizer, Inc, New York, NY 10017, NDC 0009-6582-02
Terminated Class I Drugs
- Recall started
- 15 March 2019
- Terminated
- 27 January 2021
- Reason
- Presence of Particulate Matter; glass particulates
- Distribution
- United States and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1073-2019
- 8.4% Sodium Bicarbonate Injection, USP 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL) 50 mL Single-dose fliptop vial, 25 vials per carton, Rx only Hospira, Inc. Lake Forest, IL 60045 USA ---- NDC 0409-6625-02
Terminated Class II Drugs
- Recall started
- 6 December 2018
- Terminated
- 8 October 2020
- Reason
- Superpotent Drug.
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0339-2019
- Levoxyl (levothyroxine sodium tablets, USP) tablets 112 mcg, 100-count bottle, Rx Only,Distributed by Pfizer Inc. New York, NY 10017, NDC 60793-855-01
Terminated Class II Drugs
- Recall started
- 3 October 2018
- Terminated
- 2 October 2020
- Reason
- Correct Labeled Product Mispack: confirmed report involving a single unit of properly labeled Heparin in 0.45% Sodium Chloride for Injection (NDC 0409-7651-03, Lot 87903FW) that was found inside a case of Magnesium Sulfate in Water for Injection.
- Distribution
- Nationwide in the USA and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0015-2019
- Magnesium Sulfate in Water for Injection (0.325 mEq Mg++/mL) 40 mg/mL, 20 g Total, 500 mL Single-Dose Container bag, Rx only, Hospira, Inc. Lake Forest, IL 60045 USA, NDC 0409-6729-03.
Terminated Class II Medical devices
- Recall started
- 2 October 2018
- Terminated
- 28 August 2023
- Reason
- The firm received complaints of the wrap coming apart and leaking granular material
- Distribution
- US Nationwide Distribution and PR
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0555-2019, Z-0554-2019, Z-0556-2019
- Thermacare HeatWraps Menstrual a) UPC 0573302002 b) UPC 0573302044 Product Usage: Provides heat therapy for temporary relief of minor menstrual cramp pain and associated back aches.
- Thermacare Muscle Pain Therapy HeatWraps: a) UPC 0573301314 b) UPC 0573301303 Product Usage: Provides heat therapy for temporary relief of minor muscular and joint aches and pains associated with overexertion, spra
- Thermacare HEATWRAPS JOINT PAIN THERAPY, 8 HEATWRAPS; MUSCLE PAIN THERAPY, 3 HEATWRAPS a) UPC 0573301311 b) UPC 0573301311 Product Usage: Provides heat therapy for temporary relief of minor muscular and joint ache
Terminated Class II Drugs
- Recall started
- 20 September 2018
- Terminated
- 17 September 2022
- Reason
- Lack of assurance of sterility: loss of container integrity.
- Distribution
- Nationwide in the US and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0095-2019
- Meropenem for Injection, USA (I.V.), 1 gram/vial, 25 vials per carton, Sterile, Rx Only, Manufactured for: Hospira, Inc., Lake Forest, IL 60045, USA. NDC carton: 0409-3506-01; NDC vial: 0409-3506-11
Terminated Class II Drugs
- Recall started
- 20 September 2018
- Terminated
- 8 May 2020
- Reason
- CGMP Deviations; rejected product was used to manufacture final bulk lot
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0010-2019
- Glipizide XL (glipizide) extended-release tablets 5 mg 500-tablet bottle, Rx only Distributed by: Greenstone LLC. Peapack, NJ 07977 --- NDC 59762-0541-2
Terminated Class II Drugs
- Recall started
- 19 September 2018
- Terminated
- 26 June 2020
- Reason
- Lack of assurance of sterility -Reports of loose metal ferrule crimps on vials for injection. The entire cap either lifted or dislodged while attempting to flip off the orange color plastic button.
- Distribution
- U.S.A. nationwide. The following countries received product from Lot S91616: Albania, South Africa, Israel, Afghanistan, Rwanda, Botswana, Zimbabwe and Iraq as part of the Compassionate Use Program.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0005-2019
- Elelyso (taliglucerase alfa) for injection, 200 units/vial, single-use vial, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017, NDC 0069-0106-01
Terminated Class III Drugs
- Recall started
- 28 August 2018
- Terminated
- 26 June 2020
- Reason
- Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point
- Distribution
- Nationwide USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1184-2018
- Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial, Rx only, Sterile, Manufactured for: Hospira, Inc, Lake Forest, IL 60045 USA. NDC: 0409-1140-01
Terminated Class II Drugs
- Recall started
- 28 June 2018
- Terminated
- 25 August 2022
- Reason
- Microbial Contamination of Sterile Products: Product associated with reports of adverse events indicative of infusion reactions related to microbiological contamination.
- Distribution
- Nationwide in the USA and Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1023-2018
- Daptomycin for Injection, 500 mg per vial, packaged as 1 Single-dose vial per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-0106-01.
Terminated Class I Drugs
- Recall started
- 7 February 2018
- Terminated
- 7 August 2019
- Reason
- Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0597-2018, D-0596-2018
- Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Hospira, Inc., Lake forest, IL 60045 USA. NDC: 0409-2634-01
- Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618. NDC: 0703-0110-01
Terminated Class I, Class II Drugs
- Recall started
- 20 October 2017
- Terminated
- 2 June 2020
- Reason
- SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0151-2018, D-0150-2018
- Zoloft (sertraline HCl) tablets 25 mg* 30-count bottle, Rx only, Distributed by Roerig Division of Pfizer Inc., NY, NY, 10017 NDC 0049-4960-30
- diphenoxylate hydrochloride and atropine sulfate tablets, USP, 2.5 mg/0.025 mg, a) 100-count bottle (NDC 59762-1061-1), b) 1000-count bottle (NDC 59762-1061-2), Rx Only, Distributed by: Greenstone LLC. Peapack, NJ 07977
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.