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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
Jan 16, 2018 DOXOrubicin Hydrochloride Liposome Injection, 20 mg/10 ml (2 mg/mL), 10 mL Si... Lack Of Assurance Of Sterility Class II Sun Pharmaceutical Industries, Inc.
Jan 12, 2018 Pravastatin Sodium Tablets, USP, 10 mg, 30-count bottles, packaged in 12 x 30... Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 ... Class II International Laboratories, Inc.
Jan 12, 2018 Pravastatin Sodium Tablets, USP, 20 mg, 30-count bottles, packaged in 12 x 30... Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 ... Class II International Laboratories, Inc.
Jan 11, 2018 Mitomycin 40 mg/mL Preservative Free Irrigation Volume: 10 mL SDV , Compounde... Labeling: Label Error on Declared Strength Class II Premier Pharmacy Labs Inc
Jan 11, 2018 Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 42582-113-10) and b) 500 tab... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Time-Cap Laboratories, Inc.
Jan 11, 2018 Ibuprofen Tablets, USP, 200 mg, a) 50 tablets (NDC 49483-601-05), b) 100 tabl... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Time-Cap Laboratories, Inc.
Jan 11, 2018 Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 53943-292-15), b) 100 caplet... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Time-Cap Laboratories, Inc.
Jan 11, 2018 Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 49483-604-01) and b) 500 tab... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Time-Cap Laboratories, Inc.
Jan 11, 2018 Ibuprofen Tablets USP 400 mg, a) 100 tablet (NDC 49483-602-01) and b) 500 tab... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Time-Cap Laboratories, Inc.
Jan 11, 2018 Ibuprofen Tablets USP 600 mg, a) 100 tablets (NDC 42582-112-10) and b) 500 ta... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Time-Cap Laboratories, Inc.
Jan 11, 2018 Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 42582-112-01), b) 500 tablet... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Time-Cap Laboratories, Inc.
Jan 11, 2018 Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 49483-603-01) and b) 500 tab... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Time-Cap Laboratories, Inc.
Jan 11, 2018 Ibuprofen Tablets, USP, 200 mg, a) 50 tablet (NDC 53943-291-15), b) 100 table... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Time-Cap Laboratories, Inc.
Jan 11, 2018 Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 49483-600-05), b) 100 caplet... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Time-Cap Laboratories, Inc.
Jan 11, 2018 Ibuprofen Tablets USP 400 mg, 500 tablet bottles (NDC 42582-111-18), Rx, Dist... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Time-Cap Laboratories, Inc.
Jan 10, 2018 Ibuprofen Tablets USP, 200 mg, 100-count bottles, OTC, Distributed By: Spirit... CGMP deviations: Ibuprofen is being recalled in response to previous recall Class II Spirit Pharmaceuticals, LLC
Jan 10, 2018 Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx Only, Manufactured fo... CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intende... Class II Hetero Labs, Ltd. - Unit III
Jan 9, 2018 Ibuprofen Tablets, USP 600 mg, 6 x 2500 Tablets bulk packed in double polybag... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Marksans Pharma Inc.
Jan 9, 2018 Ibuprofen Tablets, USP 200 mg, 6 x 6500 Caplets (Capsule-Shaped Tablets) bulk... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Marksans Pharma Inc.
Jan 9, 2018 Ibuprofen Tablets, USP 800 mg, 6 x 1900 Tablets bulk packed in double polybag... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Marksans Pharma Inc.
Jan 9, 2018 Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Marksans Pharma Inc.
Jan 9, 2018 Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Marksans Pharma Inc.
Jan 9, 2018 Ibuprofen Tablets, USP 400 mg, 6 x 3500 Tablets bulk packed in double polybag... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Marksans Pharma Inc.
Jan 3, 2018 Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, M... Failed Dissolution Specifications: Low out of specification results for dissolution during annual... Class II AVKARE Inc.
Dec 28, 2017 Earth's Care Eczema Lotion (2% Colloidal Oatmeal) Skin Protectant with Aloe a... Microbial Contamination of Non-Sterile Products. Class II DLC Laboratories, Inc
Dec 27, 2017 Glycopyrrolate in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 HYDROmorphone HCl in Sodium Chloride 0.9% in all doses, all strengths, and al... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Morphine Sulfate in 5% Dextrose in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Fentanyl Citrate Injection in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Labetalol HCl in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Ephedrine Sulfate Injection in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Ketamine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all pac... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Dexamethasone Sodium Phosphate added to 0.9% Sodium Chloride in all strengths... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Bupivacaine HCl in 0.9% Sodium Chloride in all doses, all strengths, and pack... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Fentanyl Citrate and Ropivacaine HCl in 0.9% Sodium Chloride in all strengths... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Nicardipine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all ... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Succinylcholine Chloride in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Potassium Chloride in 5% Dextrose in all strengths, all doses, and all packag... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Methadone HCl in 0.9% Sodium Chloride in all strengths, all doses, and all pa... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Ropivacaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all ... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Labetalol HCl in 0.9% Sodium Chloride in all strengths, all doses, and all pa... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Midazolam HCl in 5% Dextrose in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Fentanyl Citrate in 0.9% Sodium Chloride in all strengths, all doses, and all... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Adenosine Injection in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Potassium Chloride in 0.9% Sodium Chloride in all strengths, all doses, and a... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Ephedrine Sulfate in 0.9% Sodium Chloride in all strengths, all doses, and al... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Rocuronium Bromide in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Morphine Sulfate in 0.9% Sodium Chloride in all strengths, all doses, and all... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Lidocaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all pa... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Phenylephrine HCl in 0.9% Sodium Chloride in all strengths, all doses, and al... Lack of sterility assurance. Class II Pharmedium Services, 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.