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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

3,430 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 3,430 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 3,430 FDA drug recalls.

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DateProductReasonClassFirm
Jul 18, 2018 AvKARE Valsartan and Hydrochlorothiazide 80 mg/12.5 mg tablets, 90-count bott... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Avkare Incorporated
Jul 18, 2018 Valsartan, 160 mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind P... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Northwind Pharmaceuticals LLC
Jul 18, 2018 AvKARE Valsartan and Hydrochlorothiazide 320 mg/25 mg tablets 90-count bottle... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Avkare Incorporated
Jul 18, 2018 Unit Dose Valsartan Tablets, USP. 160 mg. Rx only.,Distributed by: Major Pha... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II MAJOR PHARMACEUTICALS
Jul 17, 2018 Valsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, ... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II RemedyRepack Inc.
Jul 17, 2018 Valsartan and Hydrochlorothiazide Tablets, Valsartan 320 MG and Hydrochloroth... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II A-S Medication Solutions LLC.
Jul 17, 2018 Valsartan Tablets, 80 MG, 30-count bottle (NDC 54569-6582-0, 90-count bottle ... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II A-S Medication Solutions LLC.
Jul 17, 2018 Valsartan and Hydrochlorothiazide Tablets, Valsartan 160 MG and Hydrochloroth... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II A-S Medication Solutions LLC.
Jul 17, 2018 Valsartan Tablets, 160 MG, 30-count bottle (NDC 54569-6583-0), 90-count bottl... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II A-S Medication Solutions LLC.
Jul 17, 2018 Valsartan/HCTZ 160 mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack,... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II RemedyRepack Inc.
Jul 17, 2018 Emergency First Aid Eyewash (Purified Water 98.3%), packaged in a) 4fl oz. (... CGMP Deviations Class II Longbow First Aid Products Manufactory
Jul 17, 2018 Eyewash Purified water 98.3%, Ophthalmic Solution, packaged in a) 4 FL OZ (ND... CGMP Deviations Class II Longbow First Aid Products Manufactory
Jul 16, 2018 Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/12.5 mg tablets,... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Teva Pharmaceuticals USA
Jul 16, 2018 Valsartan Tablets, USP 160 mg, 90-count bottle (NDC 0591-2169-19), 1000-count... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Teva Pharmaceuticals USA
Jul 16, 2018 Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/25 mg tablets, U... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Teva Pharmaceuticals USA
Jul 16, 2018 Valsartan Tablets, USP 320 mg, 90-count bottle (NDC 0591-2170-19), 500-count ... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Teva Pharmaceuticals USA
Jul 16, 2018 Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 80 mg/12.5 mg tablets, ... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Teva Pharmaceuticals USA
Jul 16, 2018 Valsartan Tablets, USP 40 mg, 30-count bottle (NDC 0591-2167-30), 90-count bo... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Teva Pharmaceuticals USA
Jul 16, 2018 Valsartan Tablets, USP 80 mg, 90-count bottle (NDC 0591-2168-19), 1000-count ... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Teva Pharmaceuticals USA
Jul 16, 2018 Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/12.5 mg tablets,... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Teva Pharmaceuticals USA
Jul 16, 2018 Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/25 mg tablets, U... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Teva Pharmaceuticals USA
Jul 13, 2018 Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/25 MG Tabl... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Prinston Pharmaceutical Inc
Jul 13, 2018 Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/25 MG Tabl... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Prinston Pharmaceutical Inc
Jul 13, 2018 Solco Healthcare US Valsartan, USP, 320 MG Tablets, 90-count bottle,Rx Only M... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Prinston Pharmaceutical Inc
Jul 13, 2018 Solco Healthcare US Valsartan, USP, 80 MG Tablets, 90-count bottle, Rx Only M... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Prinston Pharmaceutical Inc
Jul 13, 2018 Solco Healthcare US Valsartan, USP, 160 MG Tablets, 90-count bottles, Rx Only... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Prinston Pharmaceutical Inc
Jul 13, 2018 Solco Healthcare US Valsartan, USP, 40 MG Tablets, 30- count bottle, Rx Only,... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Prinston Pharmaceutical Inc
Jul 13, 2018 Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/12.5 MG Ta... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Prinston Pharmaceutical Inc
Jul 13, 2018 Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/12.5 MG Ta... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Prinston Pharmaceutical Inc
Jul 13, 2018 Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 80 MG/12.5 MG Tab... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Prinston Pharmaceutical Inc
Jul 3, 2018 Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application... CGMP Deviations: The manufacturer of this product recalled because they were not manufactured und... Class II Medgyn Products, Inc.
Jul 3, 2018 Potassium Chloride For Injection Concentrate syringe 40 mEq/20 mL (2 mEq/mL),... CGMP Deviations: Syringes were filled with 19mL of potassium chloride when the labels displayed a... Class II Medi-Fare Drug and Home Health Center
Jun 22, 2018 Acetylcysteine for Injection 6 g/30 mL (200 mg/mL). Rx Only. Manufactured by ... CGMP Deviations Class II Akorn, Inc.
Jun 11, 2018 Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application... CGMP Deviations: Products not manufactured under current good manufacturing practices. Class II BioDiagnostic International
May 25, 2018 X-Jow (menthol USP) Pain Gel, 1.25%, packaged in a) 4 oz. (113g) bottles (UPC... CGMP Deviations: products may be contaminated with bacteria. Class II Shadow Holdings DBA Bocchi Labs
May 25, 2018 Acne Shave 3 Step Shaving System, contains one tube Acne Shave (salicylic aci... CGMP Deviations: products may be contaminated with bacteria. Class II Shadow Holdings DBA Bocchi Labs
May 25, 2018 Acne Shave Post-Shave Moisturizer (salicylic acid), 0.5%, 3.3 FL OZ (98 mL) t... CGMP Deviations: products may be contaminated with bacteria. Class II Shadow Holdings DBA Bocchi Labs
May 25, 2018 Acne Shave (salicylic acid) Shave Cream Acne Shield, 0.5%, 5.1 FL OZ (150 mL)... CGMP Deviations: products may be contaminated with bacteria. Class II Shadow Holdings DBA Bocchi Labs
May 16, 2018 screamin' hot (capsaicin) Pain Relieving Gel, 0.03%, packaged in a) 2 OZ (57g... CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed ... Class II Ideaz Llc
May 16, 2018 screamin' menthol (menthol) Pain Relieving Gel, 4%, packaged in a) 2 OZ (57g)... CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed ... Class II Ideaz Llc
May 7, 2018 Geritrex Senna Syrup (sennosides 8.8mg), packaged in 8 FL OZ. (236 mL) bottle... CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi... Class II RIJ Pharmaceutical LLC
May 7, 2018 Preferred Plus Pharmacy Antacid Extra Strength (Aluminum Hydroxide 400mg, Mag... CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi... Class II RIJ Pharmaceutical LLC
May 7, 2018 RPC Children's Non-Aspirin (Acetaminophen 160 mg) Elixir, packaged in 4 FL. O... CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi... Class II RIJ Pharmaceutical LLC
May 7, 2018 Gericare Liquid Pain Relief Acetaminophen Cherry Flavor 160mg/5mL, packaged i... CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi... Class II RIJ Pharmaceutical LLC
May 7, 2018 RPC Senna Syrup (Sennosides 8.8mg), packaged in 8 fl oz (237 mL) bottles, RIJ... CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi... Class II RIJ Pharmaceutical LLC
May 7, 2018 Gericare Iron Supplement Elixir Ferrous Sulfate 220 mg, packaged in 16 fl oz.... CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi... Class II RIJ Pharmaceutical LLC
May 7, 2018 RPC APAP Elixir (Acetaminophen 160mg), Packaged in 16 FL. OZ. (473 mL) bottle... CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi... Class II RIJ Pharmaceutical LLC
May 7, 2018 Preferred Plus Pharmacy Antacid (Aluminum Hydroxide 200mg, Magnesium Hydroxid... CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi... Class II RIJ Pharmaceutical LLC
May 7, 2018 GeriCare Senna Syrup (Sennosides 8.8 mg), 8 fl oz (237 mL) bottles, Dist, by ... CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi... Class II RIJ Pharmaceutical LLC
May 7, 2018 Ritussin DM Dextromethorphan Hydrobormide (Dextromethorphan HBr, USP 10 mg, G... CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi... Class II RIJ Pharmaceutical 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.