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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

3,458 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 3,458 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 3,458 FDA drug recalls.

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DateProductReasonClassFirm
Oct 15, 2015 Screenses Color Sunscreen Tinted facial make-up compact, Broad Spectrum SPF 5... cGMP Deviations; product does not comply with cGMP requirements Class II Sesderma, SL
Oct 15, 2015 Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avob... cGMP Deviations; product does not comply with cGMP requirements Class II Sesderma, SL
Oct 15, 2015 Dryses Aluminum Chlorohydrate Deodorant for Women, Roll-on, 2.5 fl oz (75 mL)... cGMP Deviations; product does not comply with cGMP requirements Class II Sesderma, SL
Sep 25, 2015 FUROSEMIDE Tablets USP, 20 mg, 1000-count bottle, Rx only, Boehringer Ingelhe... CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral s... Class III Boehringer Ingelheim Roxane Inc
Sep 25, 2015 FUROSEMIDE Tablets USP, 40 mg, 1000-count bottle, Rx only, Boehringer Ingelhe... CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral s... Class III Boehringer Ingelheim Roxane Inc
Sep 16, 2015 UN1002 Air, Compressed, Medical Air, USP, Distributed by Praxair Distribution... CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air. Class III Praxair Inc.
Sep 16, 2015 UN1002 Air, Compressed, Breathing Grade, USP, Distributed by Praxair Distribu... CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air. Class III Praxair Inc.
Jul 29, 2015 Lisinopril Tablets USP, 5 mg, 1000-count bottles, Rx Only, Manufactured by: W... CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints. Class II Wockhardt Usa Inc.
Jul 29, 2015 Lisinopril Tablets USP, 20 mg, 1000-count bottles, Rx Only, Manufactured by: ... CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints. Class II Wockhardt Usa Inc.
Jul 10, 2015 Clonidine Hydrochloride Tablets, USP, 0.1 mg, 100-count bottles, Rx only, Pac... cGMP Deviations Class II PD-Rx Pharmaceuticals, Inc.
Jul 9, 2015 Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100 count HDPE bottles, Rx only... cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product... Class II Mutual Pharmaceutical Company, Inc.
Jul 9, 2015 Clonidine Hydrochloride Tablets, USP, 0.1 mg, packaged in a) 100 count (NDC 5... cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product... Class II Mutual Pharmaceutical Company, Inc.
Jul 9, 2015 Clonidine Hydrochloride Tablets, USP, 0.2 mg, packaged in a) 100 count (NDC 5... cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product... Class II Mutual Pharmaceutical Company, Inc.
Jun 5, 2015 Carb-O-Philic 40 Cream, 40%, a) 3 oz. tube (NDC 54162-640-03) b) 7 oz. tube (... CGMP Deviation: Poor container closure of the bulk storage container Class III Geritrex Corp
Jun 1, 2015 Clarithromycin tablets, USP 500mg, packaged in 10-count blisters (NDC 68084-4... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Amlodipine besylate tablets, USP 2.5mg, packaged in 10-count blisters (NDC 68... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Zonisamide capsules, USP 100mg packaged in 10-count blisters (NDC 68084-008-1... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Azithromycin tablets, USP 500mg, packaged in 10-count blisters (NDC 68084-279... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Lisinopril tablets, USP 5mg packaged in 10-count blisters (NDC 68084-060-11);... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Lisinopril tablets, USP 40mg packaged in 10-count blisters (NDC 68084-064-11)... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Azithromycin tablets, USP 250mg, packaged in 10-count blisters (NDC 68084-278... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Amlodipine besylate tablets, USP 10 mg, packaged in 10-count blisters (NDC 68... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Famotidine tablets, USP 20mg, packaged in 10-count blisters (NDC 68084-172-11... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Lisinopril tablets, USP 20mg packaged in 10-count blisters (NDC 68084-062-11)... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Amlodipine besylate tablets, USP 5mg, packaged in 10-count blisters (NDC 6808... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Lisinopril tablets, USP 10mg packaged in 10-count blisters (NDC 68084-061-11)... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Azithromycin tablets, USP 600mg, packaged in 10-count blisters (NDC 68084-464... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
May 22, 2015 Captopril Tablets, USP, 50 mg, 30 Tablets, Rx Only, Dist. By: Wockhardt USA L... cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wo... Class II Blenheim Pharmacal, Inc.
May 22, 2015 Clarithromycin Tablets, USP, 500 mg, 20 Tablets, Rx Only, Dist. By: Wockhardt... cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wo... Class II Blenheim Pharmacal, Inc.
May 12, 2015 Famotidine Tablets, USP, 20 mg Tablets, Over the Counter, Made in India and l... CGMP Deviations: Failure of the manufacturer, Wockhardt Ltd, to adequately investigate customer c... Class II Allegiant Health
Apr 29, 2015 Azithromycin Tablets, USP, 250 mg, Rx Only, packaged in a) 2 count and b) 4 c... cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm... Class II PD-Rx Pharmaceuticals, Inc.
Apr 29, 2015 Azithromycin 500 mg tablets, Rx Only, packaged in a) 1 count, b) 2 count, c) ... cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm... Class II PD-Rx Pharmaceuticals, Inc.
Apr 22, 2015 Famotodine Tablets, USP, 20 mg Tablets, Packaged in A) 30 Count Bottles (NDC... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.
Apr 22, 2015 Famotodine Tablets, USP, 20 mg Tablets, For Repacking Only, Packaged in 6500 ... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.
Apr 22, 2015 Clarithromycin Tablets, USP, 500 mg Tablets, 60 Count Bottles, Rx Only. Manuf... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.
Apr 22, 2015 Famotodine Tablets, USP, 40 mg Tablets, Packaged in A) 30 Count Bottles (NDC... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.
Apr 22, 2015 Metoprolol Succinate Extended-Release Tablets, USP, 50 mg Tablets, Packaged i... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.
Apr 22, 2015 Zolpidem Tartrate Tablets, 10 mg Tablets, CIV, Packaged in A) 100 Count Bott... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.
Apr 22, 2015 Lisinopril Tablets USP, 40 mg Tablets, Packaged in A) 100 Count Bottles (NDC:... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.
Apr 22, 2015 Amlodipine Besylate Tablets, 10 mg Tablets, Packaged as A) 90 Count Bottles... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.
Apr 22, 2015 Lisinopril Tablets USP, 20 mg Tablets, Packaged in A) 100 Count Bottles (NDC... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.
Apr 22, 2015 Amlodipine Besylate Tablets, 2.5 mg Tablets, Packaged in 90 Count Bottles, Rx... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.
Apr 22, 2015 Azithromycin Tablets, USP, 500 mg Tablets, Packaged in A) 30 Count Bottles (N... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.
Apr 22, 2015 Extended Phenytoin Sodium Capsules, USP, 100 mg Capsules, Packaged as A) 100 ... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.
Apr 22, 2015 Tamsulosin Hydrochloride Capsules, USP*, 0.4 mg Capsules, Packaged in A) 100 ... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.
Apr 22, 2015 Lamotrigine Extended-Release Tablets, 25 mg Tablets, 30 Count Bottles, Rx Onl... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.
Apr 22, 2015 Azithromycin Tablets, USP, 250 mg Tablets, Packaged in A) 30 Count Bottles (N... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.
Apr 22, 2015 Lisinopril Tablets USP, 2.5 mg Tablets, Packaged in A) 100 Count Bottles (NDC... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.
Apr 22, 2015 Metoprolol Succinate Extended-Release Tablets, USP, 25 mg Tablets, Packaged i... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.
Apr 22, 2015 Metoprolol Succinate Extended-Release Tablets, USP, 200 mg Tablets, Packaged ... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa 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.