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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

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Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Drug Recalls

6,274 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,274 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 6,274 FDA drug recalls.

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DateProductReasonClassFirm
Sep 21, 2016 Methylcobalamin Injectable (Dr. Hall Kit) - 1,000 mcg/mL, 30 mL vial Kit, Com... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Trimix Injectable 30 mg/3 mg/60 mcg/mL, a) 2 mL, b) 5 mL and c) 10 mL vials, ... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 QUAD2 (PAP/PHEN/ALPROS/ATRO) 9 mg/1 mg/10 mg/0.1 mg/mL Injectable a) 2 mL and... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Testosterone Enanthate in Grapeseed Oil Injectable, 200 mg/mL, 10 mL vial, Co... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Alprostadil 40 mcg/mL Injectable, 10 mL vials, Compounded by Wells Pharmacy N... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 20, 2016 Cyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2.5% in Sterile Wa... Lack of Assurance of Sterility; all compounded products within expiry produced using recalled fil... Class II Leiter's Compounding
Sep 20, 2016 Placebo for Prednisolone Acetate 1%, Oph Suspension, 10 mL Dropper Bottle, Co... Lack of Assurance of Sterility; all compounded products within expiry produced using recalled fil... Class II Leiter's Compounding
Sep 20, 2016 Atropine Sulfate 0.01% in 0.9% Sodium Chloride (Ophthalmic Solution) 10 mL T... Lack of Assurance of Sterility; all compounded products within expiry produced using recalled fil... Class II Leiter's Compounding
Sep 20, 2016 Brilliant Blue G 0.025% in 0.9% Sodium Chloride (Injection) 1 mL Total Volume... Lack of Assurance of Sterility; all compounded products within expiry produced using recalled fil... Class II Leiter's Compounding
Sep 20, 2016 Moxifloxacin 1 mg/mL in Sterile Balanced Salt Solution (BSS) Intravitreal In... Lack of Assurance of Sterility; all compounded products within expiry produced using recalled fil... Class II Leiter's Compounding
Sep 20, 2016 Cefuroxime Sodium 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL Total Vo... Lack of Assurance of Sterility; all compounded products within expiry produced using recalled fil... Class II Leiter's Compounding
Sep 20, 2016 Vancomycin 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in... Lack of Assurance of Sterility; all compounded products within expiry produced using recalled fil... Class II Leiter's Compounding
Sep 20, 2016 Lidocaine HCl 1% - Phenylephrine HCl 1.5% in Sterile Water for Injection (In... Lack of Assurance of Sterility; all compounded products within expiry produced using recalled fil... Class II Leiter's Compounding
Sep 20, 2016 Mitomycin 0.02% (0.2 mg/mL) in Sterile Water for Injection (Injection) 1 mL ... Lack of Assurance of Sterility; all compounded products within expiry produced using recalled fil... Class II Leiter's Compounding
Sep 16, 2016 Marcaine 0.25% (bupivacaine HCl) injection, USP, 125 mg/50 mL (2.5 mg/mL), 50... Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from fo... Class II Hospira Inc., A Pfizer Company
Sep 16, 2016 Marcaine 0.5% (bupivacaine HCl) injection, USP, 250 mg/50 mL (5 mg/mL), 50 mL... Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from fo... Class II Hospira Inc., A Pfizer Company
Sep 12, 2016 Methylcobalamin 5000 mcg/mL Injection, packaged in 1, 2, 3, 4, and 5 mL vials... Lack of Assurance of Sterility; medication was sterilized with a recalled filter Class II The Apothecary Shoppe LLC
Sep 12, 2016 Tri-Mix 18/1/10 (Papaverine 18mg, Phentolamine 1 mg, Prostaglandin 10 mcg/mL)... Lack of Assurance of Sterility; medication was sterilized with a recalled filter Class II The Apothecary Shoppe LLC
Sep 12, 2016 Phenotolamine 0.4mg/Prostaglandin 20mcg/mL packaged in 2.5 mL sterile vials, ... Lack of Assurance of Sterility; medication was sterilized with a recalled filter Class II The Apothecary Shoppe LLC
Sep 2, 2016 Eye Wash, 4 fl oz (118 mL) bottle, OTC, Distributed by: United Exchange Corp... Lack of assurance of sterility Class II United Exchange Corporation
Sep 2, 2016 Eye Irrigating Solution, 4 fl oz (118 mL) bottle, OTC, Distributed by: Rugby... Lack of assurance of sterility Class II United Exchange Corporation
Sep 2, 2016 EYE WASH, 4 fl oz. (118 mL) bottle, OTC, Distributed by: Major Pharmaceutical... Lack of assurance of sterility Class II United Exchange Corporation
Sep 2, 2016 EYE WASH, 4 fl oz. (118 mL) bottle, OTC, Distributed by: Major Pharmaceutical... Non-Sterility: Direct evidence of contamination for 2 lots based on FDA samples. Class I United Exchange Corporation
Aug 24, 2016 Phenylephrine HCI Injection, USP, 10mg/mL, packaged in a) 5 mL Vial, 50 mg/5 ... Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns... Class II Sandoz Inc
Aug 24, 2016 Ephedrine Sulfate Injection, USP, 50 mg/mL, 1 mL Fill in a 2mL Vial (NDC 6675... Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns... Class II Sandoz Inc
Aug 16, 2016 Honeywell eyesaline Eyewash Sterile Isotonic Solution, sterile water 99%, 32 ... Non Sterility; contaminated with Klebsiella pneumoniae Class I Sperian Eye & Face Protection, Inc
Aug 10, 2016 Ephedrine Sulfate Injection, USP, 50 mg/mL, Single Dose Vial, packaged in a) ... Lack of Assurance of Sterility: An FDA inspection at the facility raised concerns that product st... Class II Allergy Laboratories, Inc.
Aug 1, 2016 Sermorelin/GHRP-6 Injection 6 mg-3 mg Lyophylized I, 2 mL vial, Rx, Town and ... Non-Sterility; microbial contamination identified as Bacillus circulans Class I Town and Country Compounding and Consultation S...
Jul 28, 2016 C-PAV/PHENTOL/ATROP/PGE1, All strengths, All sizes, Rx only, Colonia Care Pha... Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were ma... Class II Colonia Care Pharmacy
Jul 28, 2016 C-PAV/PHENTOL/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy,... Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were ma... Class II Colonia Care Pharmacy
Jul 26, 2016 Hyaluronidase, 150 u/ml, 10 ml SDV, Vital Care Compounder, Hattiesburg, MS 39402 Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 Methylcobalamin 5,000mcg/ml, 1mL SDV, Rx, Vital Care Compounder, Hattiesburg,... Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 Hydroxyzine HCl, 50mg/ml Inj, 10ml MDV, Rx, Vital Care Compounder, Hattiesbur... Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 Buprenorphine, 0.6 mg/ml Injection, 20ml MDV Sterile, Rx, Vital Care Compound... Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 Pre-Op Pledget Soln + Tetracaine, (Tropicamide (1%) 0.47ml, Phenylephrine (10... Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 Apomorphine HCl 3mg/ml Sterile Injection Solution, 10 mL, MDV, Rx, Vital Care... Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 C-PAP/PHEN/PROST/ATROP 150/5/5 (Papaverine 150mg/Phentolamine 5mg/Prostagland... Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 Autologous Serum Tears, 2 vials, Rx, Vital Care Compounder, Hattiesburg, MS 3... Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 Trypan Blue 0.3%, 0.5ml vials, Rx, Vital Care Compounder, Hattiesburg, MS 39402 Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 Chlorpheniramine Maleate 10 mg/ml, 30 ml MDV, Rx, Vital Care Compounder, Hatt... Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 Brilliant Blue G (BBG) 0.025%, 0.5 ml SDV, Rx, Vital Care Compounder, Hatties... Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 C-PAP/PHEN/PROST/Atrop 150/7.5 (Papaverine 150mg/Phentolamine 7.5mg/Prostagla... Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 Pre-Op Pledget Soln, Ophthalmic Drops (Tropicamide (1%) 0.33ml, Phenylephrine... Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 DMSO 50% with Lidocaine 0.5%, 50ml SDV, Sterile, Rx, Vital Care Compounder, H... Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 MOXI/DEX/KETOROLAC 0.5%/0.1%/0.4%, #15, Vital Care Compounder, Hattiesburg, M... Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 Papaverine 150 mg / Phentolamine 5 mg vials, packaged 5.5 mL in a sterile, cl... Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 Moxifloxacin 0.5% + Dexamethazone 0.1%, 15ml vial Contains: Moxifloxacin 5mg/... Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 Papaverine 150 mg/Phentolamine 5 mg and Prostaglandin 50 mcg, packaged as 5.5... Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 Olopatadine 0.8% Ophthalmic Solution, 3ml bottle, Rx, Vital Care Compounder, ... Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 Moxifloxacin HCl 1 mg/ml (0.1mg/0.1ml) and BSS solution, 2ml Single use vial,... Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder

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.