Browse Drug Recalls

560 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 560 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 560 FDA drug recalls.

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DateProductReasonClassFirm
Aug 19, 2026 0.9% Sodium Chloride Injection, USP, 100 mL Partial Fill in 150 mL PAB Contai... Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, ... Class I B BRAUN MEDICAL INC
Aug 17, 2026 Dextrose Injection, USP, 70 %, 2000 mL bags, Rx Only, Baxter Healthcare Corpo... Presence of Particulate Matter: particulate matter identified as stainless steel particles in the... Class I Baxter Healthcare Corporation
Aug 17, 2026 0.9% Sodium Chloride Injection USP 500 mL, VIAFLEX Plastic Containers, with 2... Presence of particulate matter: Particulates identified as fiberglass Class I Baxter Healthcare Corporation
Aug 12, 2026 Lactated Ringer's Injection USP, 1000 mL EXCEL container, Rx only, L7500, B. ... Presence of Particulate matter. Class I B BRAUN MEDICAL INC
Aug 11, 2026 Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, R... Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified ... Class I American Regent, Inc.
Aug 10, 2026 Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx ... Presence of particulate matter:An internal investigation at the firm found the product to contain... Class I Fresenius Kabi USA, LLC
Aug 6, 2026 Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx ... Presence of particulate matter: glass and stopper piece Class II Mallinckrodt Hospital Products Inc.
Jul 31, 2026 Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organical... Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless st... Class I Liebel-Flarsheim Company LLC
Jul 29, 2026 SEMAGLUTIDE 5mg (1mg/mL), Glycine 25 mg (5mg/mL), 5 mL Sterile Multi-Dose Via... Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material Class II Apollo Care, LLC
Jul 29, 2026 SEMAGLUTIDE 4.5mg (0.9 mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Sub... Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material Class II Apollo Care, LLC
Jul 29, 2026 SEMAGLUTIDE 9mg (4.5 mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcu... Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material Class II Apollo Care, LLC
Jul 29, 2026 SEMAGLUTIDE 10mg (5mg/mL), Glycine 10 mg (5mg/mL), 2 mL Sterile Multi-Dose Vi... Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material Class II Apollo Care, LLC
Jul 29, 2026 SEMAGLUTIDE 20mg (5mg/mL), Glycine 20 mg (5mg/mL), 4 mL Sterile Multi-Dose Vi... Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material Class II Apollo Care, LLC
Jul 29, 2026 SEMAGLUTIDE 0.9mg (0.9 mg/mL), 1 mL Sterile Multi-Dose Vial, Rx Only, For Sub... Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material Class II Apollo Care, LLC
Jul 29, 2026 SEMAGLUTIDE 6.75mg (4.5 mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For ... Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material Class II Apollo Care, LLC
Jul 29, 2026 SEMAGLUTIDE 2.5mg (1mg/mL), Glycine 12.5 mg (5mg/mL), 2.5 mL Sterile Multi-Do... Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material Class II Apollo Care, LLC
Jul 29, 2026 SEMAGLUTIDE 2.25MG (0.9 mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For ... Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material Class II Apollo Care, LLC
Jul 29, 2026 SEMAGLUTIDE 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Sub... Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material Class II Apollo Care, LLC
Jul 29, 2026 SEMAGLUTIDE 7.5mg (5mg/mL), Glycine 7.5 mg (5mg/mL), 1.5 mL Sterile Multi-Dos... Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material Class II Apollo Care, LLC
Jul 24, 2026 Tralement (trace elements injection 4*, USP), packaged in a) 1mL Single Dose ... Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... Class II American Regent, Inc.
Jul 24, 2026 Cefazolin in Dextrose, Injection, USP, 2g / 100mL (20mg / mL) Single-Dose Inf... Presence of Particulate Matter Class I Baxter Healthcare Corporation
Jul 24, 2026 Cyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only, packaged i... Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... Class II American Regent, Inc.
Jul 24, 2026 Selenious Acid Injection, USP 12 mcg/2 mL (6 mcg/2mL), For intravenous use, p... Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... Class II American Regent, Inc.
Jul 24, 2026 AMINAOCAPROIC ACID INJECTION, USP, 250 mg/mL (5 g/20 mL), packaged in a) 20 m... Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... Class II American Regent, Inc.
Jul 24, 2026 niCARdipine Hydrochloride Injection, USP, 25 mg/10mL (2.5 mg/mL), packaged in... Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... Class II American Regent, Inc.
Jul 24, 2026 Nitroglycerin injection, USP, 50 mg/10 mL (5 mg/mL), packaged in a) 10 mL via... Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... Class II American Regent, Inc.
Jul 24, 2026 Atropine Sulfate injection, USP, 1 mg/mL, For intravenous Use, Sterile, packa... Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... Class II American Regent, Inc.
Jul 24, 2026 ACETYLCYSTEINE SOLUTION, USP, 10% (100 mg/mL), packaged in a) 4 mL Vial NOT F... Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... Class II American Regent, Inc.
Jul 24, 2026 Papaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL), packaged in a) 2mL Sing... Presence of Particulate Matter: Product contaminated with particulate matter identified as glass ... Class I American Regent, Inc.
Jul 24, 2026 ACETYLCYSTEINE SOLUTION, USP, 20% (200 mg/mL), packaged in a) 4 mL Vial NOT F... Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... Class II American Regent, Inc.
Jul 24, 2026 Multrys (Trace Elements Injection 4, USP), For intravenous infusion, packaged... Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... Class II American Regent, Inc.
Jul 24, 2026 Cyanocobalamin injection USP, 10,000 mcg/10 mL (1,000 mcg/mL), For IM or SC U... Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... Class II American Regent, Inc.
Jul 17, 2026 Cyclophosphamide for Injection, USP, 1 gram/vial, One Single-Dose Vial, Rx on... Presence of Particulate Matter; identified as stainless steel Class I Sunny Pharmtech Inc.
Jul 17, 2026 Cyclophosphamide for Injection, USP, 2 gram/vial, One Single-Dose Vial, Rx on... Presence of Particulate Matter; identified as stainless steel Class I Sunny Pharmtech Inc.
Jul 16, 2026 Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill... Presence of Particulate Matter: Hair was found in product Class II Fresenius Kabi USA, LLC
Jul 16, 2026 Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL)... Presence of Particulate Matter: Hair was found in products Class II Fresenius Kabi USA, LLC
Jul 16, 2026 Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single D... Presence of Particulate Matter: Hair was found in products Class II Fresenius Kabi USA, LLC
Jul 16, 2026 Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL)... Presence of Particulate Matter: Hair was found in products Class II Fresenius Kabi USA, LLC
Jul 16, 2026 Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5... Presence of Particulate Matter: Hair was found in products Class II Fresenius Kabi USA, LLC
May 12, 2026 DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL singl... Presence of Particulate matter: Particulate matter identified as glass. Class I SUN PHARMACEUTICAL INDUSTRIES INC
Apr 28, 2026 Lactated Ringer's Injection USP, 1000 mL container, Rx only, B. Braun Medical... Presence of Particulate Matter. Class I B BRAUN MEDICAL INC
Apr 24, 2026 Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin... Presence of particulate matter: a white thread-like structure in the cartridge Class II Lupin Pharmaceuticals Inc.
Mar 24, 2026 GE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%), Rx Only, Dist... Presence of particulate matter Class II GE Healthcare Ireland Limited
Mar 24, 2026 GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only, Dist... Presence of particulate matter Class II GE Healthcare Ireland Limited
Mar 13, 2026 Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, R... Presence of particulate matter: identified as Buprenorphine free base Class II ENDO USA, Inc.
Feb 10, 2026 Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single d... Lack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lo... Class II LEO PHARMA INC
Jan 26, 2026 ESTRADIOL, 6 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingh... Presence of Foreign substance - potential presence of metal particulate matter Class II F.H. INVESTMENTS, Inc. (dba Asteria Health)
Jan 26, 2026 Testosterone 75mg, Anastrozole 4mg, 1 Sterile Pellet, Asteria Health 432 Indu... Presence of Foreign substance - potential presence of metal particulate matter Class II F.H. INVESTMENTS, Inc. (dba Asteria Health)
Jan 26, 2026 Testosterone 100mg Anastrozole 4mg , 1 Sterile Pellet, Asteria Health 432 Ind... Presence of Foreign substance - potential presence of metal particulate matter Class II F.H. INVESTMENTS, Inc. (dba Asteria Health)
Jan 26, 2026 ESTRADIOL, 22 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birming... Presence of Foreign substance - potential presence of metal particulate matter Class II F.H. INVESTMENTS, Inc. (dba Asteria Health)

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.