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Browse Drug Recalls

186 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 186 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 186 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
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.
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.
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 Bleomycin for Injection, USP, 15 units per vial, 1 single dose glass fliptop ... Presence of particulate matter: glass Class I PFIZER
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.
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.
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.
Sep 3, 2021 AMINOSYN II 15% An Amino Acid Injection, Sulfite-Free, 2000 mL in flexible co... Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous ... Class I ICU Medical 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.
May 3, 2021 1% Lidocaine HCl Injection, USP, 300 mg/30 mL (10 mg/mL), 30 mL Single-dose v... Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, U... Class I PFIZER, INC
May 3, 2021 0.5% Bupivacaine Hydrochloride Injection, USP, 150 mg/30 mL (5 mg/mL), 30 mL ... Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, U... Class I PFIZER, INC
Mar 15, 2021 Methotrexate Injection, USP 50 mg/2mL (25 mg/mL) 5 x 2mL Single-Dose Vials, S... 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 8, 2020 LACTATED RINGER'S Injection, USP 1000 mL flexible container, Rx Only, Hospira... Presence of Particulate Matter: confirmed customer complaint for the presence of particulate matt... Class I ICU Medical Inc
Feb 3, 2020 Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL), 2 mL Single-dos... Defective Container: confirmed customer reports for vials with loose metal overseal crimp defects... Class II Pfizer Inc.
Nov 27, 2019 25% Dextrose Injection, USP 2.5 grams (250 mg/mL) 10 mL Single-dose, Rx Only,... Labeling: Incorrect or Missing Lot and/or expiration date. Class II Pfizer Inc.
Oct 25, 2019 LACTATED RINGER'S Injection, USP, 500 mL flexible container, Rx Only, Hospira... Presence of Particulate Matter. Class I ICU Medical Inc
Oct 25, 2019 0.9% SODIUM CHLORIDE INJECTION, USP, 250 mL VisIV Container, Rx Only, Hospira... Presence of Particulate Matter. Class I ICU Medical Inc
Oct 2, 2019 10% LMD in 5% Dextrose Injection Dextran 40 in Dextrose Injection, USP, 500 ... Lack of Assurance of Sterility: Bag has the potential to leak. Class II Pfizer Inc.
Sep 6, 2019 Bacteriostatic Water for Injection, USP, 30 mL vials, Rx only, Mfd. for: Hosp... Lack of Assurance of Sterility Class II Pfizer Inc.
Jul 9, 2019 Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection 40 ... Lack of Assurance of Sterility: Bags have the potential to leak. Class II Pfizer Inc.
Jul 9, 2019 Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection, 20... Lack of Assurance of Sterility: Bags have the potential to leak. Class II Pfizer Inc.
Mar 15, 2019 8.4% Sodium Bicarbonate Injection, USP 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL)... Presence of Particulate Matter; glass particulates Class I Pfizer Inc.
Feb 4, 2019 0.9% Sodium Chloride Injection, USP 1000 mL flexible container, Rx only, Hos... CGMP Deviations Class II ICU Medical Inc
Oct 8, 2018 5% Dextrose Injection, USP, Rx Only, a) 25 mL NDC 0409-7923-20; b) 250 mL NDC... Lack of Assurance of Sterility; bags have the potential to leak Class II ICU Medical Inc
Oct 8, 2018 0.9% Sodium Chloride Injection, USP Rx Only a) 250 mL NDC 0409-7983-02; b) 15... Lack of Assurance of Sterility; bags have the potential to leak Class II ICU Medical Inc
Oct 3, 2018 Magnesium Sulfate in Water for Injection (0.325 mEq Mg++/mL) 40 mg/mL, 20 g T... Correct Labeled Product Mispack: confirmed report involving a single unit of properly labeled Hep... Class II Pfizer Inc.
Sep 20, 2018 Meropenem for Injection, USA (I.V.), 1 gram/vial, 25 vials per carton, Steril... Lack of assurance of sterility: loss of container integrity. Class II Pfizer Inc.
Jun 28, 2018 Daptomycin for Injection, 500 mg per vial, packaged as 1 Single-dose vial per... Microbial Contamination of Sterile Products: Product associated with reports of adverse events in... Class II PFIZER
May 31, 2018 0.45% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake... Lack of assurance of sterility: Bags have potential to leak. Class II ICU Medical Inc
May 31, 2018 0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake ... Lack of assurance of sterility: Bags have potential to leak. Class II ICU Medical Inc
May 31, 2018 0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only ,Hospira, Inc. Lake ... Lack of assurance of sterility: Bags have potential to leak. Class II ICU Medical Inc
May 31, 2018 5% Dextrose Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, I... Lack of assurance of sterility: Bags have potential to leak. Class II ICU Medical Inc
May 31, 2018 0.9% Sodium Chloride Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake ... Lack of assurance of sterility: Bags have potential to leak. Class II ICU Medical Inc
Feb 20, 2018 Labetalol Hydrochloride Injection, USP, 100 mg/ 20 mL (5 mg/mL), 20 mL Multid... Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and ... Class II Hospira Inc. A Pfizer Company
Feb 7, 2018 Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Sin... Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty o... Class I Pfizer Inc.
Sep 1, 2017 Sterile Water for Injection, USP Single Dose 100 mL vials, Rx only, Manufactu... Non-Sterility: cracked or chipped glass at the neck of Sterile Water for Injection vials. Class II Pfizer Inc.
Aug 30, 2017 Vancomycin Hydrochloride for Injection, USP. 750 mg. Sterile Powder. Rx Only... Presence of Particulate Matter: glass particulate found in vial Class I Pfizer Inc.
Aug 22, 2017 Levophed (norepinephrine bitartrate) injection, USP, 4 mg/4 mL (1mg/mL), 4mL ... Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used... Class II Pfizer Inc.
Aug 22, 2017 HYDROmorphone HCl Injection, USP, 2 mg/mL, 1mL Single-use vial, packaged in c... Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used... Class II Pfizer Inc.
Jul 26, 2017 Hydromorphone Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), 5 mL Singl... Presence of Particulate Matter: Silicone oil Class II HOSPIRA INC, LAKE FOREST
Jul 26, 2017 Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Si... Presence of Particulate Matter: Silicone oil Class II HOSPIRA INC, LAKE FOREST

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.