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Vehicle Safety

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

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.

Clear
DateProductReasonClassFirm
Nov 1, 2019 Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL per c... CGMP Deviations: Presence of NDMA impurity detected in product. Class II American Health Packaging
Nov 1, 2019 Hydrocodone Bitartrate and Homatropine Methlybromide Oral Solution 5 mg/1.5 m... Presence of Foreign Substance: Black particles were found in the lots during retain sample inspec... Class II KVK-Tech, Inc.
Oct 31, 2019 LETS GEL KIT Convenience Pack (To prepare 100 mL LETS GEL), Contains: LETS Po... Microbial contamination of non-sterile product. Class II Fagron, Inc
Oct 30, 2019 Potassium Phosphate, Monobasic, Crystal, NF, Multi-Compendial, Bulk Pharmaceu... Failed Stability Specifications: Product exceeds compendia and firm's specifications for iron con... Class II Avantor Performance Materials Inc
Oct 28, 2019 Lannett Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL Rx Only Di... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Lannett Company, Inc.
Oct 25, 2019 Novitium Pharma Ranitidine Capsules 300 mg 100 capsules Rx Only Manufactured ... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Novitium Pharma LLC
Oct 25, 2019 Novitium Pharma Ranitidine Capsules 150 mg 500 capsules Rx Only Manufactured ... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Novitium Pharma LLC
Oct 25, 2019 Novitium Pharma Ranitidine Capsules 150 mg 60 capsules Rx Only Manufactured b... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Novitium Pharma LLC
Oct 25, 2019 Novitium Pharma Ranitidine Capsules 300 mg 30 capsules Rx Only Manufactured b... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Novitium Pharma LLC
Oct 23, 2019 Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 80 tablets per ... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 50 tablets per... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 30 tablets per ... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 95 t... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 24 tablets per... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 160 tablets per... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 90 tablets per... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 40 t... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 200 tablets pe... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 24 t... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 65 tablets per... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 65 t... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 150 tablets per... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 95 tablets per... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 8 tablets. [ND... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Alprazolam Tablets, USP 0.5 mg, 500-count bottles, Rx only, Manufactured for:... Presence of Foreign Substance Class II Mylan Pharmaceuticals Inc.
Oct 23, 2019 Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 90 t... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 60 tablets per ... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 22, 2019 Regular Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Compa... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Sanofi-Aventis U.S. LLC
Oct 22, 2019 Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, ... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Sanofi-Aventis U.S. LLC
Oct 22, 2019 Regular Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Compan... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Sanofi-Aventis U.S. LLC
Oct 22, 2019 Cool Mint Tablets Maximum Strength Zantac 150 mg Sanofi Distributed by: Chatt... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Sanofi-Aventis U.S. LLC
Oct 22, 2019 Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Compan... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Sanofi-Aventis U.S. LLC
Oct 22, 2019 Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Compan... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Sanofi-Aventis U.S. LLC
Oct 22, 2019 Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219,... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Sanofi-Aventis U.S. LLC
Oct 22, 2019 Estradiol Vaginal Inserts USP, 10 mcg, packaged in a) 8-count Vaginal Inserts... Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator. Class II Glenmark Pharmaceuticals Inc., USA
Oct 22, 2019 Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Compan... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Sanofi-Aventis U.S. LLC
Oct 22, 2019 Maximum Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Compan... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Sanofi-Aventis U.S. LLC
Oct 22, 2019 Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Compa... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Sanofi-Aventis U.S. LLC
Oct 22, 2019 Cool Mint Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sa... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Sanofi-Aventis U.S. LLC
Oct 22, 2019 Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Compan... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Sanofi-Aventis U.S. LLC
Oct 18, 2019 Miracle Facelift Masque, All Natural, The Miracle in a Bottle, 2 fl. oz./60 m... Marketed without an Approved NDA/ANDA Class II Basic Reset Inc.
Oct 18, 2019 Basic Reset CBD Reset 750 True Full Spectrum Cinnamon, 750 mg CBD, 1 fl. oz. ... Marketed without an Approved NDA/ANDA Class II Basic Reset Inc.
Oct 18, 2019 Basic Reset Nuovi Skin Toner, Refined Ionyte, 4 FL. OZ., 118.3 mL bottle, Dis... Marketed without an Approved NDA/ANDA Class II Basic Reset Inc.
Oct 18, 2019 Basic Reset Earth Wash Cleaner and Personal Care, Eco Friendly, Non Toxic, 2 ... Marketed without an Approved NDA/ANDA Class II Basic Reset Inc.
Oct 18, 2019 Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Ph... Failed Dissolution Specification: Low out of specification dissolution results. Class II Mylan Pharmaceuticals Inc.
Oct 18, 2019 Basic Reset CBD Reset 750 True Full Spectrum Natural Flavor 750 mg CBD 1 fl. ... Marketed without an Approved NDA/ANDA Class II Basic Reset Inc.
Oct 18, 2019 Basic Reset CBD Reset 750 True Full Spectrum Wintergreen, 750 mg CBD, 1 fl. o... Marketed without an Approved NDA/ANDA Class II Basic Reset Inc.
Oct 18, 2019 BIOGENYX True Full Spectrum CBD Oil Natural Flavor, 1 fl. oz. (30 mL) bottle,... Marketed without an Approved NDA/ANDA Class II Basic Reset Inc.
Oct 18, 2019 Nuovi Firming Masque, Renew and Reset, 2 fl. oz. 59 mL bottle, Made in USA ex... Marketed without an Approved NDA/ANDA Class II Basic Reset Inc.
Oct 18, 2019 BIOGENYX True Full Spectrum CBD Oil Wintergreen, 1 fl. oz. (30 mL) bottle, 75... Marketed without an Approved NDA/ANDA Class II Basic Reset 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.