Browse Drug Recalls

17,936 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 17,936 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 17,936 FDA drug recalls.

DateProductReasonClassFirm
Aug 24, 2026 Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) ... Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclo... Class II Hikma Pharmaceuticals USA INC.
Aug 13, 2026 Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx o... Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance c... Class II Apotex Corp.
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 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 10, 2026 Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus,... CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for micro... Class II Church & Dwight Co., Inc.
Aug 7, 2026 Carbamazepine Tablets, USP, 200mg, packaged in a)1000-count bottles (NDC 5140... CGMP deviations: tablets with black specks. Class II Golden State Medical Supply Inc.
Aug 6, 2026 Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottles, Rx... Subpotent Drug Class II ACCORD HEALTHCARE, INC.
Aug 6, 2026 Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000-count bottles, Rx ... Subpotent Drug Class II ACCORD HEALTHCARE, INC.
Aug 6, 2026 Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), packaged in a) 90-count ... Subpotent Drug Class II ACCORD HEALTHCARE, INC.
Aug 6, 2026 Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), packaged in a) 90-coun... Subpotent Drug Class II ACCORD HEALTHCARE, INC.
Aug 6, 2026 Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottles, Rx ... Subpotent Drug Class II ACCORD HEALTHCARE, INC.
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.
Aug 6, 2026 Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottles, Rx ... Subpotent Drug Class II ACCORD HEALTHCARE, INC.
Aug 6, 2026 Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles, Rx Onl... Subpotent Drug Class II ACCORD HEALTHCARE, INC.
Aug 6, 2026 Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), packaged in a) 90-coun... Subpotent Drug Class II ACCORD HEALTHCARE, INC.
Aug 6, 2026 Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, Rx ... Subpotent Drug Class II ACCORD HEALTHCARE, INC.
Aug 6, 2026 Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 1000-count bottles, Rx... Subpotent Drug Class II ACCORD HEALTHCARE, INC.
Aug 6, 2026 Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx O... Subpotent Drug Class II ACCORD HEALTHCARE, INC.
Aug 6, 2026 Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count ... Subpotent Drug Class II ACCORD HEALTHCARE, INC.
Aug 5, 2026 Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufac... CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity. Class II Zydus Pharmaceuticals (USA) Inc
Aug 4, 2026 Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefille... Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of ... Class I Fresenius Kabi USA, LLC
Aug 4, 2026 Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manu... Failed Dissolution Specifications Class II Novartis Pharmaceuticals Corporation
Aug 3, 2026 Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured ... CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing Class II SUN PHARMACEUTICAL INDUSTRIES INC
Aug 3, 2026 Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for:... Failed content uniformity specifications. Class II Lupin Pharmaceuticals Inc.
Aug 3, 2026 TADALAFIL USP, 1.00 KG, 1KG(1000gm)-bag, Rx only, "For Prescription Compoundi... CGMP Deviations:Noted during FDA inspection Class II Shoolin Pharma Chem LLP
Aug 3, 2026 SILDENAFIL CITRATE USP, 1.00KG, 1.00KG-bag Net Wt. Rx only " For Prescription... CGMP Deviations:Noted during FDA inspection Class II Shoolin Pharma Chem LLP
Aug 3, 2026 TADALAFIL USP, 0.500 KG, 0.500KG(500gm)-bag, Rx only, "For Prescription Compo... CGMP Deviations:Noted during FDA inspection Class II Shoolin Pharma Chem LLP
Aug 3, 2026 TADALAFIL USP, 0.100 KG, 0.1KG(100gm)-bag, Rx only, "For Prescription Compoun... CGMP Deviations:Noted during FDA inspection Class II Shoolin Pharma Chem LLP
Aug 3, 2026 SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescriptio... CGMP Deviations:Noted during FDA inspection Class II Shoolin Pharma Chem LLP
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 30, 2026 CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx On... Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles. Class II Heritage Pharmaceuticals Inc
Jul 29, 2026 PEMRYDI RTU(pemetrexed injection), 500 mg/50 mL (10 mg/mL), Single-dose vial,... Discolored solution. The firm has received market complaints reporting green to dark green discol... Class II Shilpa Medicare Limited
Jul 29, 2026 PEMRYDI RTU (pemetrexed injection), 100 mg/10 mL (10 mg/mL), Single-dose via... Discolored solution. The firm has received market complaints reporting green to dark green discol... Class II Shilpa Medicare Limited
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 CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per dropper bottle, St... Lack of assurance of sterility. The recall is due to potential contamination Class II Prestige Brands Holdings
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 28, 2026 Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), For Intravenous ... Lack of Assurance of Sterility Class II Regeneron Pharmaceuticals Inc
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.

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.