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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

17,897 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 17,897 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 17,897 FDA drug recalls.

DateProductReasonClassFirm
Nov 27, 2018 Amlodipine and Valsartan Tablets 5 mg/320 mg, (a) 30-count bottles (NDC 0093-... CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... Class II Teva Pharmaceuticals USA
Nov 27, 2018 Amlodipine and Valsartan Tablets 10 mg/320 mg (a) 30-count bottles (NDC 0093... CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... Class II Teva Pharmaceuticals USA
Nov 27, 2018 Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/320 mg/25 mg, (... CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... Class II Teva Pharmaceuticals USA
Nov 27, 2018 Amlodipine and Valsartan Tablets 10 mg/160 mg, (a) 30-count bottles (NDC 0093... CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... Class II Teva Pharmaceuticals USA
Nov 27, 2018 Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/12.5 mg, ... CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... Class II Teva Pharmaceuticals USA
Nov 27, 2018 Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/25 mg, (... CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... Class II Teva Pharmaceuticals USA
Nov 27, 2018 Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 5 mg/160 mg/12.5 mg, ... CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... Class II Teva Pharmaceuticals USA
Nov 27, 2018 Aprepitant Capsules, USP 40 mg, 1 capsule Unit Blister Pack, Rx Only, Manufa... Shortfill: Aprepitant capsules 40 mg is being recalled due to customer reports of missing capsule... Class III Glenmark Pharmaceuticals Inc., USA
Nov 26, 2018 Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 ... Superpotent Drug: recalled lots may have higher concentration of ibuprofen. Class II Tris Pharma Inc.
Nov 26, 2018 infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 m... Superpotent Drug: recalled lots may have higher concentration of ibuprofen. Class II Tris Pharma Inc.
Nov 26, 2018 Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 ... Superpotent Drug: recalled lots may have higher concentration of ibuprofen. Class II Tris Pharma Inc.
Nov 21, 2018 Norepinephrine 8 mg (32 mcg/mL) added to 0.9% Sodium Chloride Injection 250 m... Incorrect excipient: Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium C... Class III QuVa Pharma, Inc.
Nov 20, 2018 Valsartan Tablets, USP, 40 mg, 30-count bottle, Rx Only, Made in India, Manuf... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained i... Class II Mylan Pharmaceuticals Inc.
Nov 20, 2018 Valsartan Tablets, USP, 160 mg, 90-count bottle, Rx Only, Made in India, Manu... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained i... Class II Mylan Pharmaceuticals Inc.
Nov 20, 2018 Valsartan and Hydrochlorothiazide Tablets, USP, 320 mg/25 mg, (a) 500-count b... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained i... Class II Mylan Pharmaceuticals Inc.
Nov 20, 2018 Valsartan Tablets, USP, 80 mg, 90-count bottles, Rx Only, Made in India, Manu... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained i... Class II Mylan Pharmaceuticals Inc.
Nov 20, 2018 Germ Bloc Health Hand Sanitizer Foam (benzalkonium chloride 0.13%) 7.5fl.oz./... Microbial Contamination of Non-Sterile Product: Presence of Pseudomonas aeruginosa in product Class II AVKARE Inc.
Nov 20, 2018 Amlodipine and Valsartan Tablets, USP,10 mg/160 mg, 30-count bottle, Rx Only,... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained i... Class II Mylan Pharmaceuticals Inc.
Nov 20, 2018 Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30-count bottle, Rx Only... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained i... Class II Mylan Pharmaceuticals Inc.
Nov 20, 2018 Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30-count bottle, Rx Only,... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained i... Class II Mylan Pharmaceuticals Inc.
Nov 20, 2018 Valsartan Tablets, USP, 320 mg, 90-count bottle, Rx Only, Made in India, Manu... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained i... Class II Mylan Pharmaceuticals Inc.
Nov 19, 2018 Human Chorionic Gonadotropin 3000 IU, Rx only, Pharm D. Solutions 1304 South ... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Pharm D Solutions, LLC
Nov 16, 2018 SHEER DesenZ Desensitizing Treatment, Rx Only, Potassium Nitrate 12mg per fil... cGMP violations noted during the firm's most recent inspection. Class II CAO Group, Inc.
Nov 16, 2018 fas.TRACT Coagulative Hemostatic Gel, 10% Ferric Sulfate Kit, Rx Only, (3) 3c... cGMP violations noted during the firm's most recent inspection. Class II CAO Group, Inc.
Nov 16, 2018 FastStat Topical Hemostat Introductory Kit, 10% Ferric Sulfate 10%, Rx Only, ... cGMP violations noted during the firm's most recent inspection. Class II CAO Group, Inc.
Nov 16, 2018 BeeGentle Honey Flavored Topical Anesthetic, Active ingredient Benzocaine 20%... cGMP violations noted during the firm's most recent inspection. Class II CAO Group, Inc.
Nov 15, 2018 SODIUM CHLORIDE INJECTION, USP, 0.9%, 20 mL Single Dose Vial, packaged in a 2... Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect state... Class I Fresenius Kabi USA, LLC
Nov 15, 2018 SODIUM CHLORIDE INJECTION, USP, 0.9%, 10 mL Single Dose Vial, packaged in a 2... Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect state... Class I Fresenius Kabi USA, LLC
Nov 14, 2018 Quetiapine Tablets USP 400 mg, 100 tablet bottles, Rx Only, Manufactured by:... Presence of Foreign Substance; metal shard found in tablet Class II Ascend Laboratories LLC
Nov 9, 2018 Medi-Stat Foam, Antimicrobial Hand Soap, Chloroxylenol 0.5%, 1250 mL (42.3 fl... Labeling: Label mix-up - the label on the product may not match the formula in the bottle. Class II Ecolab Inc
Nov 9, 2018 Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100-count Un... Cross contamination with other products: This sub-recall is being initiated in support of the rec... Class III AMERICAN HEALTH PACKAGING
Nov 9, 2018 Equi-Soft Foam, Antimicrobial Hand Soap, 0.55% Benzalkonium Chloride, 25 fl o... Labeling: Label mix-up - the label on the product may not match the formula in the bottle. Class II Ecolab Inc
Nov 8, 2018 INFed (Iron Dextran Injection USP) 100 mg elemental iron/2 mL (50 mg/mL), Rx ... Failed Stability Specification: out of specification for iron content. Class II ALLERGAN
Nov 8, 2018 ERBITUX CETUXIMAB Injection, 200 mg/100 mL (2 mg/mL), 100 mL per single-use v... Labeling: Missing label; potential for missing primary container label on the vial. Class III Eli Lilly & Co
Nov 7, 2018 Nitrofurantoin Monohydrate/Macrocrystals capsules,100 mg, packaged in HDPE 60... Cross contamination with other products: Product is being recalled due to the potential presence ... Class III RemedyRepack Inc.
Nov 7, 2018 Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx... Failed Dissolution Specification: Out-of-Specification results were observed for dissolution at 1... Class II Dr. Reddy's Laboratories, Inc.
Nov 6, 2018 Antacid Tablets, Calcium Carbonate chewable tablets, 750mg, 60-count bottle, ... Presence of foreign substance: Product found to contain metal particles. Class II L. Perrigo Company
Nov 6, 2018 AMITIZA (lubiprostone) capsules 8 mcg. 60-count bottle, Rx Only. Marketed by:... Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month ... Class III Takeda Development Center Americas, Inc.
Nov 6, 2018 Megestrol Acetate Oral Suspension, USP 625 mg/5mL, 150 mL bottle, Rx only, Di... Failed Stability Specifications: Out-of-Specification results obtained for particle size distribu... Class III Breckenridge Pharmaceutical, Inc.
Nov 5, 2018 puriton EYE RELIEF DROPS, 0.5 oz (15 ml) bottle, Kadesh Inc., NDC#7079600115,... Non-Sterility: Product manufactured under non-sterile production conditions. Class I Kadesh International
Nov 2, 2018 Isosorbide Dinitrate Tablets, USP 10 mg,100-count bottles, Rx Only Manufactur... Cross Contamination with Other Products Class II Sandoz Inc
Nov 2, 2018 IRBESARTAN Tablets, USP 150 mg (a) 30-count bottle (NDC 60429-641-30), (b) 90... CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine ... Class II Golden State Medical Supply Inc.
Nov 2, 2018 IRBESARTAN Tablets, USP 75 mg 90-count bottle, Rx Only, Manufactured by: SciG... CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine ... Class II Golden State Medical Supply Inc.
Nov 2, 2018 Isosorbide Dinitrate Tablets, USP 20 mg, 100-count bottles, Rx Only, Distribu... Cross Contamination with Other Products Class II Sandoz Inc
Nov 2, 2018 Isosorbide Dinitrate Tablets, USP 5 mg,100-count bottles, Rx Only Manufacture... Cross Contamination with Other Products Class II Sandoz Inc
Nov 2, 2018 Curaplex Epi Kit NOT FOR IV USE, #8600-01120, Epi-Safe Kit 8600-01 120 contai... Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use... Class II Bound Tree Medical, LLC
Nov 2, 2018 Curaplex Epi Safe Kit, 8600-01102 TRAINING ONLY, Rx Only, Distributed by Sarn... Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use... Class II Bound Tree Medical, LLC
Nov 2, 2018 Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, packaged in ... Cross Contamination with Other Products Class III Sandoz Inc
Nov 2, 2018 Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, 100-count bo... Cross Contamination with Other Products Class III Sandoz Inc
Nov 2, 2018 curaplex Epi Safe Administration and Training Kits, #8600-01100, Contains: 2 ... Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use... Class II Bound Tree Medical, LLC

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.