thejoe Pfizer Inc.

Pfizer Inc.: 120 FDA recall reports

Every drug recall the FDA has published for Pfizer Inc.. The fault, and how the agency graded it.

120Reports

16Class I

18Ongoing

2025-08-27Most recent

16 Class I on this page

Class I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class II	69
Class III	35
Class I	16

By year reported

Year	Reports
2013	15
2014	9
2015	4
2016	6
2017	12
2018	10
2019	16
2020	7
2021	11
2022	14
2023	6
2024	5
2025	5

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only, Distributed by Hospira, Inc., Lake Fore

D-0590-2025 · Class II · reported 2025-08-27 · Ongoing

Why it was recalled: Lack of Assurance of Sterility.
Product: 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.
Where it went: U.S. Nationwide
How much: 49,620 vials

Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx only, Hospira, Inc., Lake Fores

D-0591-2025 · Class II · reported 2025-08-27 · Ongoing

Why it was recalled: Lack of Assurance of Sterility.
Product: 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.
Where it went: U.S. Nationwide
How much: 15,750 vials

Bicillin L-A (penicllin G benzathine injectable suspension), 1,200,000 units per 2 mL, 2 mL-vial, Rx Only, Dis

D-0544-2025 · Class II · reported 2025-08-06 · Ongoing

Why it was recalled: CGMP Deviations; particulates identified during visual inspection
Product: 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 - 60793-701-02
Where it went: Nationwide in the USA
How much: 50,855 2 mL vials

Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units per 4 mL, 4ml-vial, Rx Only, Dis

D-0545-2025 · Class II · reported 2025-08-06 · Ongoing

Why it was recalled: CGMP Deviations; particulates identified during visual inspection
Product: 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-60793-702-04
Where it went: Nationwide in the USA
How much: 19,279 vials

DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose Vial, carton of 10 Fliptop Vials,

D-0489-2025 · Class II · reported 2025-07-02 · Ongoing

Why it was recalled: Discoloration; discolored solution from cracked vials
Product: 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. NDC Carton: 0409-2344-02; NDC Vial: 0409-2344-62
Where it went: Nationwide in the USA
How much: 98,410 vials

Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose Carpuject, Sterile Cartridge Un

D-0565-2024 · Class II · reported 2024-07-03 · Ongoing

Why it was recalled: Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Product: 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 60045 USA. NDC: 0409-2339-24
Where it went: US Nationwide and Puerto Rico.
How much: 220,400 cartridges

Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpuject, Sterile Cartridge Unit with

D-0564-2024 · Class II · reported 2024-07-03 · Ongoing

Why it was recalled: Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Product: 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 USA. NDC: 0409-2012-03
Where it went: US Nationwide and Puerto Rico.
How much: 84,710 cartridges

Class I

4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5 mEq/mL), Glass ABBOJECT Unit of Use Syringe, For Intra

D-0233-2024 · Class I · reported 2024-01-24 · Ongoing

Why it was recalled: Presence of Particulate Matter; identified as glass
Product: 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), 0409-5534-14 (case).
Where it went: Nationwide in the USA and Puerto Rico.
How much: 34000 Cartons

Class I

8.4 % Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), Lifeshield, Glass ABBOJECT Unit of Use Syring

D-0234-2024 · Class I · reported 2024-01-24 · Ongoing

Why it was recalled: Presence of Particulate Matter; identified as glass
Product: 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), 0409-6637-14 (case).
Where it went: Nationwide in the USA and Puerto Rico.
How much: 21200 Cartons

Class I

Atropine Sulfate Injection, USP 1 mg/10 mL (0.1 mg/mL), Lifeshield, Glass ABBOJECT Unit of Use Syringe, Rx Onl

D-0235-2024 · Class I · reported 2024-01-24 · Ongoing

Why it was recalled: Presence of Particulate Matter; identified as glass
Product: 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 (case).
Where it went: Nationwide in the USA and Puerto Rico.
How much: 24400 Cartons

Class I

2% Lidocaine HCl Injection, USP, 100mg/5mL(20mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial an

D-0102-2024 · Class I · reported 2023-11-15 · Terminated

Why it was recalled: Presence of Particulate Matter: identified as glass.
Product: 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
Where it went: Nationwide in the US and Puerto Rico. The products were not distributed to government accounts or foreign consignees.
How much: 3,200 vials

Class I

4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJECT Unit of Use Syringe, packaged a

D-0100-2024 · Class I · reported 2023-11-15 · Terminated

Why it was recalled: Presence of Particulate Matter: identified as glass.
Product: 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
Where it went: Nationwide in the US and Puerto Rico. The products were not distributed to government accounts or foreign consignees.
How much: 24,900 vials

Class I

1% Lidocaine HCl Injection, USP, 50mg/5mL(10mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and

D-0101-2024 · Class I · reported 2023-11-15 · Terminated

Why it was recalled: Presence of Particulate Matter: identified as glass.
Product: 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
Where it went: Nationwide in the US and Puerto Rico. The products were not distributed to government accounts or foreign consignees.
How much: 21,390 vials

MEKTOVI (binimetinib) tablets, 15 mg, 180-count bottle, Rx only, Distributed by: Array BioPharma Inc., a wholl

D-0532-2023 · Class III · reported 2023-04-19 · Ongoing

Why it was recalled: 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.
Product: 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
Where it went: Nationwide in the USA
How much: 1,926 Bottles

Class I

Vancomycin Hydrochloride for Injection, USP, 1.5 g/vial, Sterile powder, Single-dose Fliptop Vial, 10 vials p

D-0184-2023 · Class I · reported 2023-02-01 · Terminated

Why it was recalled: Presence of Particulate Matter: Glass particulate matter detected in injectable.
Product: 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 0409-3515-01
Where it went: USA nationwide and Puerto Rico
How much: 89,700 vials

Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium Chloride Injection, 1,000 mL bag

D-0097-2023 · Class II · reported 2023-01-11 · Completed

Why it was recalled: Lack of assurance of sterility: Bags have the potential to leak.
Product: 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 Forest, IL 60045 USA,
Where it went: Nationwide in the USA.
How much: 62,088 bags

Aminophylline Injection, USP 250 mg/10 mL (25 mg/mL) 25x10 mL Single-dose vial, Rx only, Distributed by Hospi

D-0003-2023 · Class II · reported 2022-10-12 · Terminated

Why it was recalled: Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial.
Product: 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)
Where it went: Distributed in the United States and Puerto Rico.
How much: 103,150 10 mL vials

Class I

PROPOFOL Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL glass fliptop vial (NDC 0409-4699-54)

D-1540-2022 · Class I · reported 2022-09-21 · Terminated

Why it was recalled: Presence of particulate matter
Product: 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 Forest, IL 60045 USA
Where it went: USA Nationwide
How much: 5,390 vials

Class I

Propofol Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL per glass fliptop vial (NDC 0409-4699-

D-1301-2022 · Class I · reported 2022-08-03 · Terminated

Why it was recalled: Presence of particulate matter: particulate identified as a beetle.
Product: 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., Lake Forest, IL 60045 USA
Where it went: USA Nationwide
How much: 54,000 vials

Accupril (Quinapril HCl Tablets) 10 mg, 90 Tablets Rx only NDC 0071-0530-23 Distributed by: Parke-Davis Divis

D-0872-2022 · Class II · reported 2022-05-25 · Terminated

Why it was recalled: CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
Product: 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
Where it went: Nationwide and Puerto Rico
How much: 2079 bottles

Accupril (Quinapril HCl Tablets) 20 mg, 90 Tablets, Rx only NDC 0071-0532-23 Distributed by: Parke-Davis Divi

D-0873-2022 · Class II · reported 2022-05-25 · Terminated

Why it was recalled: CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
Product: 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
Where it went: Nationwide and Puerto Rico
How much: 10,304 bottles

Accupril (Quinapril HCl Tablets) 40 mg, 90 Tablets, Rx only NDC 0071-0535-23 Distributed by: Parke-Davis Divi

D-0874-2022 · Class II · reported 2022-05-25 · Terminated

Why it was recalled: CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
Product: 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
Where it went: Nationwide and Puerto Rico
How much: 8346 bottles

quinapril and hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets bottles, Rx Only, Distributed by: Greensto

D-0758-2022 · Class II · reported 2022-04-13 · Terminated

Why it was recalled: CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Product: 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
Where it went: Nationwide
How much: 2442 bottles

quinapril HCl/hydrochlorothiazide tablets, 20 mg/12.5 mg*, 90 Tablets bottles, Rx Only, Distributed by: Greens

D-0759-2022 · Class II · reported 2022-04-13 · Terminated

Why it was recalled: CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Product: 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
Where it went: Nationwide
How much: 21108 bottles

Accuretic (quinapril HCl/hydrochlorothiazide) tablets, 20 mg/12.5 mg*, 90 Tablets, Rx Only, Distributed by: Pa

D-0761-2022 · Class II · reported 2022-04-13 · Terminated

Why it was recalled: CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Product: 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 .
Where it went: Nationwide
How much: 195 bottles

Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 10 mg/12.5 mg*, 90 Tablets bottles, Rx Only, Distribute

D-0754-2022 · Class II · reported 2022-04-13 · Terminated

Why it was recalled: CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Product: 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.
Where it went: Nationwide
How much: 53 bottles

quinapril HCl/hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets, Rx Only, Distributed by: Greenstone, LLC,

D-0760-2022 · Class II · reported 2022-04-13 · Terminated

Why it was recalled: CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Product: 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
Where it went: Nationwide
How much: 1104 bottles

Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/25 mg, 90 tablets bottles, Rx Only, Distributed b

D-0757-2022 · Class II · reported 2022-04-13 · Terminated

Why it was recalled: CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Product: 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.
Where it went: Nationwide
How much: 265 bottles

Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/12.5 mg, 90 tablets bottles, Rx Only Distributed

D-0756-2022 · Class II · reported 2022-04-13 · Terminated

Why it was recalled: CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Product: 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.
Where it went: Nationwide
How much: 1364 bottles

Accuretic (quinapril HCl/hydrochlorothiazide) Tablets 10 mg/12.5 mg 90 tablets bottle, Rx Only, Distributed by

D-0755-2022 · Class II · reported 2022-04-13 · Terminated

Why it was recalled: CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Product: 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
Where it went: Nationwide
How much: 160 bottles

Showing the 30 most recent of 120. The rest are searchable at the FDA enforcement report database.

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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