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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

14,380 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14,380 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 14,380 FDA drug recalls, Class II.

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DateProductReasonClassFirm
Apr 18, 2017 FOLINIC ACID MDV (CALIF) 5MG/ML INJ, Injection, 5mg/mL, Rx only, packaged in ... Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due ... Class II Key Pharmacy and Compounding Center
Apr 18, 2017 TRI MIX 45.45/27.27/0.45 5ML MDV MCG/MG/MG/ML INJ, Injection, 45.45mcg/27.27m... Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due ... Class II Key Pharmacy and Compounding Center
Apr 18, 2017 TRI MIX 40/30/2 5ML MDV MCG/MG/MG/ML INJ, Injection, 40mcg/30mg/2mg/mL, Rx on... Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due ... Class II Key Pharmacy and Compounding Center
Apr 18, 2017 FOLINIC ACID MDV INJ, Injection, 10 mg/mL, Rx only, packaged in 2mL and 10 mL... Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due ... Class II Key Pharmacy and Compounding Center
Apr 18, 2017 HYDROXO-B12 PBF MDV 10MG/ML INJ, Injection, 10mg/mL, Rx only, packaged in a 5... Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due ... Class II Key Pharmacy and Compounding Center
Apr 18, 2017 SODIUM BICARB 50ML MDV 8.4% (2 MOSMOL/ML) INJ, Injection, 8.40%, Rx only, 5... Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due ... Class II Key Pharmacy and Compounding Center
Apr 18, 2017 PGE1/CPZ 5ML MDV 20MCG/1MG/ML INJ, Injection, 20mcg/1mg/mL, Rx only, 5 mL Gla... Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due ... Class II Key Pharmacy and Compounding Center
Apr 18, 2017 METHYL-B12 5ML MDV (CALIF) 1MG/ML INJ, Injection, 1mg/mL, Rx only, 5 mL Glass... Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due ... Class II Key Pharmacy and Compounding Center
Apr 18, 2017 TRI MIX 13/30/0.8 5ML MDV MCG/MG/MG/ML INJ, Injection, 13mcg/30mg/0.8mg/mL, R... Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due ... Class II Key Pharmacy and Compounding Center
Apr 18, 2017 TRI MIX 10/30/0.5 *5ML* MDV MCG/MG/MG/ML INJ, Injection,10mcg/30mg/0.5mg/mL, ... Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due ... Class II Key Pharmacy and Compounding Center
Apr 18, 2017 CO-Q-10 OIL 20ML MDV (CALIF) 25MG/ML INJ, Injection, 25mg/mL, Rx only, 20mL... Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due ... Class II Key Pharmacy and Compounding Center
Apr 18, 2017 TRI MIX 6/18/0.6 5ML MDV MCG/MG/MG/ML INJ, Injection, 6mcg/18mg/0.6mg/mL, Rx ... Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due ... Class II Key Pharmacy and Compounding Center
Apr 18, 2017 PGE1 5ML MDV INJ, Injection, 40mcg/mL, Rx only, 5mL glass/Multiple Dose vial... Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due ... Class II Key Pharmacy and Compounding Center
Apr 18, 2017 VIT C/GSH 1.25%-1.25% OPHTH, Ophthalmic, 1.25%, Rx only, 15 mL Plastic/ Multi... Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due ... Class II Key Pharmacy and Compounding Center
Apr 18, 2017 SODIUM CHLORIDE INH PF GV 0.9% SOLN, Inhalation Solution, 0.90%, Rx only, 5mL... Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due ... Class II Key Pharmacy and Compounding Center
Apr 17, 2017 ESTRONE USP, packaged in a) 1g bottle (NDC: 58597-8049-2), c) 5g bottle (NDC:... cGMP Deviations; lack of quality assurance. Class II American Pharmaceutical Ingredients LLC
Apr 17, 2017 EEMT HS (esterified estrogens and methyltestosterone) 0.625 mg/1.25 mg, table... CGMP deviations: Lots were recalled due to sub-potency and cGMP violations. Class II Syntho Pharmaceuticals, Inc.
Apr 17, 2017 EEMT (esterified estrogens and methyltestosterone) 1.25 mg/2.5 mg, tablets,10... CGMP deviations: Lots were recalled due to sub-potency and cGMP violations. Class II Syntho Pharmaceuticals, Inc.
Apr 13, 2017 Estradiol (17-B-Estradiol; Estra-1,3,5(10)-triene-3, 17B-diol; Oestradiol) Pl... CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall n... Class II Spectrum Laboratory Products, Inc.
Apr 13, 2017 Levonorgestrel, U.S.P. active pharmaceutical ingredient, packaged in 1 kg con... CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall n... Class II Spectrum Laboratory Products, Inc.
Apr 6, 2017 Estrone, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-... cGMP Deviations: lack of quality assurance at the API manufacturer. Class II Fagron, Inc
Apr 6, 2017 Cyanocobalamin 1 mg/mL/ Methionine 25 mg/mL/ Inositol 50 mg/mL/ Choline 50 mg... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Isomeric Pharmacy Solution, LLC
Apr 6, 2017 Triamcinolone Diacetate 40 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Onl... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Isomeric Pharmacy Solution, LLC
Apr 6, 2017 Testosterone Cypionate 200 mg/mL, Testosterone Propionate 20 mg/mL, 30 mL Mul... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Isomeric Pharmacy Solution, LLC
Apr 6, 2017 Triamcinolone Acetonide 40 mg/mL, Lidocaine HCl 10 mg/mL , 10 mL Multi-Dose V... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Isomeric Pharmacy Solution, LLC
Apr 6, 2017 Fentanyl Citrate (Preservative Free) 10 mcg per mL (1,000 mcg per 100 mL) 100... Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expira... Class II PharMedium Services, Llc
Apr 6, 2017 Estriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-... cGMP Deviations: lack of quality assurance at the API manufacturer. Class II Fagron, Inc
Apr 6, 2017 Methylprednisolone Acetate 40 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Isomeric Pharmacy Solution, LLC
Apr 6, 2017 Phenylephrine 2.5%, Tropicamide 1%, 15 mL Multi-Dose Ophthalmic (spelled Opth... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Isomeric Pharmacy Solution, LLC
Apr 6, 2017 Fentanyl Citrate (Preservative Free) 20 mcg per mL (2,000 mcg per 100 mL) 100... Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expira... Class II PharMedium Services, Llc
Apr 6, 2017 Methylprednisolone Acetate 80 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Isomeric Pharmacy Solution, LLC
Apr 3, 2017 ESTRONE, USP Bulk, in a) 100 mgs (NDC 38779-0891-05), b) 1 gram (NDC 38779-08... cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a r... Class II Medisca, Inc.
Apr 3, 2017 ESTRADIOL, USP (Hemihydrate)(Micronized), in a) 100 mg (NDC 38779-0869-07), b... cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a r... Class II Medisca, Inc.
Apr 3, 2017 Refresh Tears (Carboxymethylcellulose Sodium Solution) 0.5%, Lubricant Eye Dr... Labeling: Not elsewhere classified; product labeling lacks a NDC number, net weight information a... Class II Cell Distributors
Apr 3, 2017 ESTRIOL, USP (Micronized) Bulk, in a) 5 grams (NDC 38779-0732-03), b) 25 gram... cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a r... Class II Medisca, Inc.
Apr 3, 2017 ESTRADIOL, USP Bulk (Hemihydrate), in a) 25 g (NDC 38779-2261-04) and b) 100... cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a r... Class II Medisca, Inc.
Mar 30, 2017 Alka-Seltzer Original ( 325 mg Aspirin (NSAID), 1916 mg Analgesic, Sodium bic... Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister... Class II Bayer HealthCare Pharmaceuticals, Inc.
Mar 30, 2017 Alka-Seltzer Gold (1000 mg Anhydrous citric acid, 344 mg Antacid Potassium b... Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister... Class II Bayer HealthCare Pharmaceuticals, Inc.
Mar 30, 2017 Alka-Seltzer Extra Strength (500 mg Aspirin (NSAID), 1985 mg Analgesic Sodium... Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister... Class II Bayer HealthCare Pharmaceuticals, Inc.
Mar 28, 2017 Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 USP nystatin units a... Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability Class II Taro Pharmaceuticals U.S.A., Inc.
Mar 28, 2017 hCG Body Shaper, Highly Purified Human Chorionic Gonadotrophin 5000 IU, Collo... Marketed without an Approved NDA/ANDA; FDA analysis has found the product to be tainted with huma... Class II Gary Wood
Mar 24, 2017 Estriol Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufac... cGMP Deviations; lack of quality assurance. Class II Qinhuangdao Zizhu Pharmaceutical, Co.
Mar 24, 2017 Testosterone Micronized, Bulk, Rx only, For Prescription Compounding, Manufac... cGMP Deviations; lack of quality assurance. Class II Qinhuangdao Zizhu Pharmaceutical, Co.
Mar 24, 2017 Estradiol Micronized Bulk, Rx only, For Prescription Compounding, Manufacture... cGMP Deviations; lack of quality assurance. Class II Qinhuangdao Zizhu Pharmaceutical, Co.
Mar 24, 2017 Estrone Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufac... cGMP Deviations; lack of quality assurance. Class II Qinhuangdao Zizhu Pharmaceutical, Co.
Mar 24, 2017 Estradiol Non-Micronized, USP, Bulk, Rx only, For Prescription Compounding, M... cGMP Deviations; lack of quality assurance. Class II Qinhuangdao Zizhu Pharmaceutical, Co.
Mar 24, 2017 Ethinyl Estradiol Micronized, USP, Bulk, Rx only, For Prescription Compoundin... cGMP Deviations; lack of quality assurance. Class II Qinhuangdao Zizhu Pharmaceutical, Co.
Mar 24, 2017 Levonorgestrel Non-Micronized, USP, Bulk, Rx only, For Prescription Compoundi... cGMP Deviations; lack of quality assurance. Class II Qinhuangdao Zizhu Pharmaceutical, Co.
Mar 22, 2017 Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 20... Defective Delivery System: Elevated number of units with out of specification results for leak rate. Class II GlaxoSmithKline, LLC
Mar 21, 2017 Atorvastatin Calcium Tablets, 10 mg*, 100-count Unit Dose Tablets (10 x 10) p... Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identifi... Class II Mylan Institutional, Inc. (d.b.a. UDL Laborator...

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.