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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

Consumer Safety

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
Jan 7, 2019 Cephalexin for Oral Suspension USP, 250mg/5mL, 200 mL (when mixed), Rx only, ... CGMP Deviation; manufacturing batch record could not be located Class II Lupin Pharmaceuticals Inc.
Jan 3, 2019 Vecuronium Bromide for Injection 20 mg* *1mg/mL when reconstituted to 20 mL L... Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromid... Class I Sun Pharmaceutical Industries, Inc.
Jan 3, 2019 Vecuronium Bromide for Injection 10 mg*, *1mg/mL when reconstituted to 10 mL ... Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromid... Class I Sun Pharmaceutical Industries, Inc.
Jan 2, 2019 Cefdinir for Oral Suspension USP, 125mg/5mL, packaged in a) 60mL (NDC 68180-7... CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to ... Class II Lupin Pharmaceuticals Inc.
Jan 2, 2019 Cidofovir Injection 375mg/5mL (75mg/mL) vial injection. 5 mL vials, Rx only, ... Lack of Assurance of Sterility: complaints received about dried powder on the outside of bottle Class II Heritage Pharmaceuticals, Inc.
Jan 2, 2019 Methocarbamol liquid 100mg/ml, RX, glass vial Lack of sterility assurance. Class II Hiers Enterprises, LLC dba Northwest Compoundin...
Jan 2, 2019 Cefdinir for Oral Suspension USP, 250mg/5mL, packaged in a) 60mL (NDC 68180-7... CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to ... Class II Lupin Pharmaceuticals Inc.
Jan 2, 2019 Lidocaine gel 2%, RX, plastic dropper Lack of sterility assurance. Class II Hiers Enterprises, LLC dba Northwest Compoundin...
Jan 2, 2019 Hydroxyprogesterone liquid, 250mg/ml, RX, glass vial Lack of sterility assurance. Class II Hiers Enterprises, LLC dba Northwest Compoundin...
Jan 2, 2019 Glutathione liquid, 200mg/ml, Rx Lack of sterility assurance. Class II Hiers Enterprises, LLC dba Northwest Compoundin...
Jan 2, 2019 MIC B vitamin liquid 25/50/50/1/1/1mg/ml RX glass vial Lack of sterility assurance. Class II Hiers Enterprises, LLC dba Northwest Compoundin...
Jan 2, 2019 Lidocaine gel 1%, RX, plastic dropper Lack of sterility assurance. Class II Hiers Enterprises, LLC dba Northwest Compoundin...
Jan 2, 2019 HCG liquid, 1000u/ml, RX, glass vial, various Lack of sterility assurance. Class II Hiers Enterprises, LLC dba Northwest Compoundin...
Jan 2, 2019 Testosteron Cypionate liquid 200mg/ml, RX, glass vial Lack of sterility assurance. Class II Hiers Enterprises, LLC dba Northwest Compoundin...
Jan 2, 2019 Cyclosporin liquid 2%, Rx, plastic dropper bottle, dry eye Lack of sterility assurance. Class II Hiers Enterprises, LLC dba Northwest Compoundin...
Jan 2, 2019 Cyclosporin liquid 0.2%, Rx, plastic dropper bottle Lack of sterility assurance. Class II Hiers Enterprises, LLC dba Northwest Compoundin...
Jan 2, 2019 Cyclosporin liquid 0.05%, Rx, plastic dropper bottle Lack of sterility assurance. Class II Hiers Enterprises, LLC dba Northwest Compoundin...
Jan 2, 2019 Vitamin B12 liquid 1000mcg/ml, RX, glass vial Lack of sterility assurance. Class II Hiers Enterprises, LLC dba Northwest Compoundin...
Jan 2, 2019 Glutathione liquid, 100mg/ml Lack of sterility assurance. Class II Hiers Enterprises, LLC dba Northwest Compoundin...
Jan 2, 2019 0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) a.) 1 mL in... Subpotent Class II PharMEDium Services, LLC.
Jan 2, 2019 Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextro... Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing. Class II Baxter Healthcare Corporation
Jan 2, 2019 Lidocaine/Epinepherine liquid 1%/ 1:1000, RX, glass vial These include inj... Lack of sterility assurance. Class II Hiers Enterprises, LLC dba Northwest Compoundin...
Jan 2, 2019 Epinephrine liquid 1:1000, RX, glass vial Lack of sterility assurance. Class II Hiers Enterprises, LLC dba Northwest Compoundin...
Jan 2, 2019 Cyclosporin liquid 1%, Rx, plastic dropper bottle Lack of sterility assurance. Class II Hiers Enterprises, LLC dba Northwest Compoundin...
Jan 2, 2019 Cyclosporin liquid 0.5%, Rx, plastic dropper bottle Lack of sterility assurance. Class II Hiers Enterprises, LLC dba Northwest Compoundin...
Dec 31, 2018 Valsartan and Hydrochlorothiazide tablets USP 160 mg/25 mg, 90-count bottle, ... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... Class II Aurobindo Pharma USA Inc.
Dec 31, 2018 Valsartan and Hydrochlorothiazide tablets USP 160mg/12.5 mg, 90-count bottle,... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... Class II Aurobindo Pharma USA Inc.
Dec 31, 2018 Amlodipine and Valsartan Tablets USP 5 mg/320 mg, 30-count bottles, Rx Only, ... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... Class II Aurobindo Pharma USA Inc.
Dec 31, 2018 Valsartan and Hydrochlorothiazide tablets USP 320 mg/25 mg, 90-count bottles,... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... Class II Aurobindo Pharma USA Inc.
Dec 31, 2018 Valsartan and Hydrochlorothiazide tablets USP 320mg/12.5 mg, 90-count bottle,... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... Class II Aurobindo Pharma USA Inc.
Dec 31, 2018 Amlodipine and Valsartan Tablets USP 5 mg/160 mg, 30-count bottles, Rx Only, ... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... Class II Aurobindo Pharma USA Inc.
Dec 31, 2018 Valsartan Tablets USP 320 mg, 90 count bottles, Rx only, Distributed by: Aur... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... Class II Aurobindo Pharma USA Inc.
Dec 31, 2018 Valsartan Tablets USP 80 mg, 90 count bottles, Rx only, Distributed by: Aurob... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... Class II Aurobindo Pharma USA Inc.
Dec 31, 2018 Valsartan and Hydrochlorothiazide tablets USP 80 mg/12.5 mg, 90-count bottle,... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... Class II Aurobindo Pharma USA Inc.
Dec 31, 2018 Amlodipine and Valsartan Tablets USP 10 mg/160 mg, 30-count bottles, Rx Only,... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... Class II Aurobindo Pharma USA Inc.
Dec 31, 2018 Valsartan tablets USP 320 mg, 90-count bottles, Rx Only, Manufactured for: Au... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... Class II Aurobindo Pharma USA Inc.
Dec 31, 2018 Amlodipine and Valsartan Tablets USP 10 mg/320 mg. 30-count bottles, Rx Only,... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... Class II Aurobindo Pharma USA Inc.
Dec 31, 2018 Valsartan Tablets USP 40 mg, 30 count bottles, Rx only, Distributed by: Auro... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... Class II Aurobindo Pharma USA Inc.
Dec 31, 2018 Amlodipine and Valsartan Tablets USP 10mg/160mg, 30 count bottles, Manufactur... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... Class II Aurobindo Pharma USA Inc.
Dec 31, 2018 Valsartan Tablets USP 160 mg, 90 count bottles, Rx only, Distributed by: Auro... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... Class II Aurobindo Pharma USA Inc.
Dec 26, 2018 Estradiol Vaginal Inserts, USP, 10 mcg, Rx only, packaged in a) 8 count (NDC ... Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator Class II Glenmark Pharmaceuticals Inc., USA
Dec 26, 2018 LOPERAMIDE HCL TABLETS USP, 2 mg, ANTI-DIARRHEAL, 24 caplets per carton, OTC... Labeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel i... Class III Sun Pharmaceutical Industries, Inc.
Dec 21, 2018 Nitrofurantoin Oral Suspension, USP, 25mg/5mL, 230 mL bottle, Rx only, Manufa... Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specificat... Class II LUPIN SOMERSET
Dec 20, 2018 OZURDEX (dexamethasone intravitreal implant) 0.7 mg), 1 single-use plastic ap... GMP Deviations: A silicone particulate was noted in Ozurdex. Class II Allergan, PLC.
Dec 20, 2018 LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP, 100 mg/12.5 mg, a) ... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... Class II Torrent Pharma Inc.
Dec 20, 2018 LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP 50 mg/12.5 mg, a) 90... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... Class II Torrent Pharma Inc.
Dec 20, 2018 Temozolomide Capsules, 180 mg, packaged in a 14 count bottles, Rx only, Mfd, ... Failed Dissolution Specifications Class III Amerigen Pharmaceuticals Inc.
Dec 20, 2018 LOSARTAN POTASSIUM TABLETS, USP, 50 mg, a) 30-count bottle (NDC: 13668-409-30... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... Class II Torrent Pharma Inc.
Dec 20, 2018 Temozolomide Capsules, 20 mg, packaged in a a) 5-count (NDC 43975-253-05) and... Failed Dissolution Specifications Class III Amerigen Pharmaceuticals Inc.
Dec 20, 2018 Ceftriaxone for Injection USP, 250 mg, packaged in a) one Single Use Vial (ND... Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredde... Class I Lupin Pharmaceuticals 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.