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Browse Drug Recalls

138 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 138 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 138 FDA drug recalls.

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DateProductReasonClassFirm
Aug 4, 2025 Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), R... Lack of Assurance of Sterility. Class II PFIZER INC
Aug 4, 2025 Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only, Distri... Lack of Assurance of Sterility. Class II PFIZER INC
Jul 29, 2025 Levoxyl (levothyroxine sodium tablets, USP), 50 mcg, 100-count bottle, Rx onl... Subpotent drug Class II Pfizer
Jul 10, 2025 Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units... CGMP Deviations; particulates identified during visual inspection Class II Pfizer Inc.
Jul 10, 2025 Bicillin L-A (penicllin G benzathine injectable suspension), 1,200,000 units ... CGMP Deviations; particulates identified during visual inspection Class II Pfizer Inc.
May 28, 2025 DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose V... Discoloration; discolored solution from cracked vials Class II Pfizer Inc.
Jan 17, 2025 Inflectra (infliximab-dyyb), For injection, 100mg per vial, packaged in 10 mL... cGMP Deviations: Product intended for quarantine was inadvertently distributed. Class II McKesson
May 20, 2024 Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpu... Lack of Assurance of Sterility-The potential for incomplete crimp seals. Class II Pfizer Inc.
May 20, 2024 Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dos... Lack of Assurance of Sterility-The potential for incomplete crimp seals. Class II Pfizer Inc.
Apr 30, 2024 Cardura XL (doxazosin) extended release tablets 4mg, 30-count bottles, Rx Onl... Failed Impurities/Degradation Specifications Class II Viatris Inc
Apr 30, 2024 Cardura XL (doxazosin) extended release tablets 8mg, 30-count bottles, Rx Onl... Failed Impurities/Degradation Specifications Class II Viatris Inc
Dec 21, 2023 Atropine Sulfate Injection, USP 1 mg/10 mL (0.1 mg/mL), Lifeshield, Glass ABB... Presence of Particulate Matter; identified as glass Class I Pfizer Inc.
Dec 21, 2023 8.4 % Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), Lifeshield, ... Presence of Particulate Matter; identified as glass Class I Pfizer Inc.
Dec 21, 2023 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5 mEq/mL), Glass ABBOJE... Presence of Particulate Matter; identified as glass Class I Pfizer Inc.
Oct 2, 2023 1% Lidocaine HCl Injection, USP, 50mg/5mL(10mg/mL), Glass ABBOJECT Unit of Us... Presence of Particulate Matter: identified as glass. Class I Pfizer Inc.
Oct 2, 2023 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJEC... Presence of Particulate Matter: identified as glass. Class I Pfizer Inc.
Oct 2, 2023 2% Lidocaine HCl Injection, USP, 100mg/5mL(20mg/mL), Glass ABBOJECT Unit of U... Presence of Particulate Matter: identified as glass. Class I Pfizer Inc.
Mar 8, 2023 MEKTOVI (binimetinib) tablets, 15 mg, 180-count bottle, Rx only, Distributed ... Labeling: Incorrect or Missing Lot and/or Exp Date: The carton and bottle labels state an expiry... Class III Pfizer Inc.
Dec 29, 2022 Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium... Lack of assurance of sterility: Bags have the potential to leak. Class II Pfizer Inc.
Dec 22, 2022 Vancomycin Hydrochloride for Injection, USP, 1.5 g/vial, Sterile powder, Sing... Presence of Particulate Matter: Glass particulate matter detected in injectable. Class I Pfizer Inc.
Sep 27, 2022 Aminophylline Injection, USP 250 mg/10 mL (25 mg/mL) 25x10 mL Single-dose via... Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial. Class II Pfizer Inc.
Aug 22, 2022 PROPOFOL Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL glass... Presence of particulate matter Class I Pfizer Inc.
Jul 13, 2022 Propofol Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL per g... Presence of particulate matter: particulate identified as a beetle. Class I Pfizer Inc.
Apr 22, 2022 Accupril (Quinapril HCl Tablets) 40 mg, 90 Tablets, Rx only NDC 0071-0535-23... CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits. Class II Pfizer Inc.
Apr 22, 2022 Accupril (Quinapril HCl Tablets) 20 mg, 90 Tablets, Rx only NDC 0071-0532-23... CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits. Class II Pfizer Inc.
Apr 22, 2022 Accupril (Quinapril HCl Tablets) 10 mg, 90 Tablets Rx only NDC 0071-0530-23 ... CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits. Class II Pfizer Inc.
Apr 13, 2022 Nitrostat (Nitroglycerin Sublingual Tablets, USP) 0.4 mg/tablet, 25-count bot... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Mar 21, 2022 Accuretic (quinapril HCl/hydrochlorothiazide) Tablets 10 mg/12.5 mg 90 tablet... CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the accepta... Class II Pfizer Inc.
Mar 21, 2022 Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/12.5 mg, 90 tabl... CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the accepta... Class II Pfizer Inc.
Mar 21, 2022 Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/25 mg, 90 tablet... CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the accepta... Class II Pfizer Inc.
Mar 21, 2022 quinapril HCl/hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets, Rx Only,... CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the accepta... Class II Pfizer Inc.
Mar 21, 2022 Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 10 mg/12.5 mg*, 90 Tab... CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the accepta... Class II Pfizer Inc.
Mar 21, 2022 Accuretic (quinapril HCl/hydrochlorothiazide) tablets, 20 mg/12.5 mg*, 90 Tab... CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the accepta... Class II Pfizer Inc.
Mar 21, 2022 quinapril HCl/hydrochlorothiazide tablets, 20 mg/12.5 mg*, 90 Tablets bottles... CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the accepta... Class II Pfizer Inc.
Mar 21, 2022 quinapril and hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets bottles, ... CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the accepta... Class II Pfizer Inc.
Nov 30, 2021 5% Dextrose Injection, USP, 50 mL ADD-Vantage Unit, Rx only, Distributed by H... Lack of sterility assurance: bag has the potential to leak. Class II Pfizer Inc.
Aug 23, 2021 Lyrica CR (pregabalin) extended release tablets, 330 mg, 30-count bottles, Rx... Failed Dissolution Specifications Class II Viatris
Aug 13, 2021 Chantix (varenicline) tablets 1 mg, 56 Tablets, Rx only, Distributed by Pfiz... CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim ac... Class II Pfizer Inc.
Aug 13, 2021 Chantix (varenicline) tablets 0.5mg/1mg, 56 Tablets, Rx only, Distributed by... CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim ac... Class II Pfizer Inc.
Aug 13, 2021 Chantix (varenicline) tablets 1 mg, Carton containing 4 blister packs of 14 t... CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim ac... Class II Pfizer Inc.
Aug 13, 2021 Chantix (varenicline) tablets 0.5mg, 56 Tablets, Rx only, Distributed by Pfi... CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim ac... Class II Pfizer Inc.
Jun 9, 2021 Chantix (varenicline)Tablets, Contains: 1 Starting Week (0.5 mg* x 11 tablets... CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acc... Class II Pfizer Inc.
Jun 9, 2021 Chantix (varenicline) tablets, 1 mg, 56 Tablets, Rx Only, Distributed by Pfiz... CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acc... Class II Pfizer Inc.
Jun 9, 2021 Chantix (varenicline) tablets, 0.5mg*, 56 Tablets, Rx Only, Distributed by Pf... CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim ac... Class II Pfizer Inc.
May 3, 2021 Sterile Water for Inj., USP, 25 x 100 mL Single Dose Vials per carton, Rx onl... Presence of Particulate Matter: particulate matter identified as an insect in one vial. Class II Pfizer Inc.
Mar 15, 2021 Chantix (varenicline) Tablets Continuing Month Box Contains: 4 Continuing Wee... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 LEVOXYL Tablets, USD, 150MCG, 100-count bottle, Rx Only, Distributed by Pfize... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 LYRICA (pregabalin) capsules, 200mg 90-count bottle, Rx Only, Distributed by:... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Jul 20, 2020 Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL) 2 mL Single-dose... Lack of Assurance of Sterility; potential loose metal overseal crimp defects. Class II Pfizer Inc.
May 29, 2020 Unasyn (ampicillin sodium/sulbacatam) for injection, 1.5 g* per vial, Rx Only... Presence of Particulate Matter: particulate matter identified after reconstitution. Class II Pfizer Inc.

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.