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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

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
May 26, 2017 Methocarbamol, USP, packaged in a) 100 g container (NDC: 58597-8023-6, b) 500... CGMP Deviations: Lack of quality assurance at the API manufacturer. Class II American Pharmaceutical Ingredients LLC
May 2, 2017 Famotidine for Oral Suspension USP, 40 mg/5 mL, 50 mL bottle, Rx only, Manufa... CGMP Deviations Class III Lupin Pharmaceuticals Inc.
Apr 19, 2017 Estradiol 20 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count an... CGMP deviations- Lack of Quality Assurance Class II Qualgen
Apr 19, 2017 Estradiol 12.5 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count,... CGMP deviations- Lack of Quality Assurance Class II Qualgen
Apr 19, 2017 Estradiol 10 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 1... CGMP deviations- Lack of Quality Assurance Class II Qualgen
Apr 19, 2017 Estradiol 22 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, ... CGMP deviations- Lack of Quality Assurance Class II Qualgen
Apr 19, 2017 Estradiol 18 mg pellet , 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count... CGMP deviations- Lack of Quality Assurance Class II Qualgen
Apr 19, 2017 Estradiol 25 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, ... CGMP deviations- Lack of Quality Assurance Class II Qualgen
Apr 19, 2017 Estradiol 6 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12... CGMP deviations- Lack of Quality Assurance Class II Qualgen
Apr 19, 2017 Shield and Protect Moisture Barrier Cream, 1.1% Clotrimazole, Net Weight 4 oz... GMP Deviations; product may not meet cGMP requirements Class II Gentell, Inc
Apr 19, 2017 Estradiol 15 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 1... CGMP deviations- Lack of Quality Assurance Class II Qualgen
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 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 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 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.
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.
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 8, 2017 Triamcinolone 40 mg/mL 2 mL Single-Dose Vial for Injection, Preservative Free... CGMP Deviations Class II Isomeric Pharmacy Solution, LLC
Feb 28, 2017 Clindamycin Phosphate Topical Solution USP, 1%, packaged in a) 30 mL applicat... CGMP Deviations: an expired active ingredient was used in the manufacture of these recalled lots. Class III G & W Laboratories, Inc.
Feb 16, 2017 HealthA2Z CHEWABLE Aspirin (NSAID) 81 mg, Orange Flavor, 36 Chewable Tablets,... cGMP deviations - presence of rubber particles found loose in the bulk product. Class II Allegiant Health
Feb 10, 2017 REVERSE DML LOTION (Ketoconazole 2%, Metronidazole 2%, sulfacetamide sodium 1... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 LP CREAM (Lidocaine 15%/Prilocaine 5%), Rx only, Synergy RX, 4901 Morena Blvd... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 CUSTOM LIGHTENING/BRIGHTENING CREAM, Rx only, Synergy RX, 4901 Morena Blvd # ... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 TRI-BLEACHING CREAM (Retinoic Acid 0.1%, Hydroquinone 4%, Fluocinolone 0.01%)... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 HYDROCORTISONE 2.5% WITH ALOE VERA CREAM, Rx only, Synergy RX, 4901 Morena Bl... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 CLOBETASOL 0.05% IN OLEA BASE, CLOBETASOL 0.05% IN OROBASE, CLOBETASOL 0.05% ... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 INTIMATE BLEACHING CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San D... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 HYDROQUINONE 28% SOLUTION, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San ... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 KOJIC ACID 8%/AZELAIC ACID 15% CREAM, Rx only, Synergy RX, 4901 Morena Blvd #... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 ULTRA LITE CREAM (Hydroquinone 8%), Rx only, Synergy RX, 4901 Morena Blvd # 5... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 CLARIFYING CREAM (Retinoic acid 0.025%, Salicylic Acid 1%, Green tea powder, ... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 HYDROQUINONE CREAM in all strengths including 4%, 5%,6%, 7%, 8%, HYDROQUINON... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 GENTLE SUPREME BLEACHING CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 HCG in all strength including: 2,400, 9600,12,000 UNIT POWDER VIAL DROPS, HCG... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 ROSACEA CREAM ( Metronidazole 1%, Niacinamide 4%), Rx only, Synergy RX, 4901 ... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 ENHANCED RETIN ANTI-WRINKLE CREAM, ENHANCED RETIN ANTI-WRINKLE CREAM 0.1%, EN... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 UREA 40% Cream, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 9... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 AZELAIC ACID 15% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Die... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx

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.