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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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Bridge Safety624,000 bridge inspections Aviation Safety30,000+ NTSB aviation events Dam Safety92,600 dam safety records Water Safety433,000+ public water systems Railroad Safety438,000+ rail crossings Pipeline Safety8,800+ pipeline incidents State DashboardsSafety grades for all 50 states ZIP ReportAny 5-digit ZIP across 9 datasets

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Browse Drug Recalls

17,897 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 17,897 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 17,897 FDA drug recalls.

DateProductReasonClassFirm
Dec 17, 2018 ICB-Complex, injection,Inositol/Choline/B1/B2/B3/B5/B6/B12/Leucine/Carnitine/... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Nicotinamide Adenine Dinucleotide, 0.5 mg, injection, 10mL vial, Rx Only, Pro... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Epithalon, 15mg injection, Rx Only, Promise Pharmacy Compounding Specialists ... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Ipamorelin, 15mg, injection, Rx Only, Promise Pharmacy Compounding Specialist... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 IGF-1-LR3, 3 mg injection, Rx Only, Promise Pharmacy Compounding Specialists ... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Amino Blend Injection, Ornithine/Arginine/Lysine/Lidocaine 75 mg/75 mg/75 mg/... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Sermorelin/GHRP2/GHRP6, 9 mg/9 mg/9 mg injection, Rx Only, Promise Pharmacy C... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Niacinamide injection, 100mg/mL, 5mL vial, Rx Only, Promise Pharmacy Compound... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Ipamorelin+Sermorelin, 15mg/15mg, injection, Rx Only, Promise Pharmacy Compou... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 HCG, Human chorionic gonadotropin 2,000 units, injection, Rx Only, Promise Ph... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 HCG, Human chorionic gonadotropin 11,000 units, injection, Rx Only, Promise P... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Prednisolone and Gatifloxacin and Bromfenac Ophthalmic Solution, 1%/0.5%/0.09... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Pyridoxine HCl, 100 mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Com... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Sermorelin/GHRP2/GHRP6 6mg/3mg/3mg injection, Rx Only, Promise Pharmacy Compo... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Testosterone 0.1% cream, 30 grams, Rx only, Duren's Health Mart Pharmacy 215 ... Lack of Processing Controls. Class II Duren Health Mart Pharmacy
Dec 17, 2018 Bremelanotide (PT 141), 20mg injection, Rx Only, Promise Pharmacy Compounding... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 14, 2018 Lubrisine eye drops (polyethylene glycol 400 0.4% and Propylene glycol 0.3%),... Lack of Sterility Assurance and Incorrect/Undeclared excipient: Product was found to contain unde... Class I Results RNA, LLC
Dec 14, 2018 Nevirapine Extended Release Tablets, 400 mg, 30-count bottle, Rx Only, Manufa... Failed Dissolution Specifications. Class II Cipla Limited
Dec 11, 2018 Oxybutynin Chloride Tablets, USP, 5 mg, 500-count bottle, Rx only, Mfd. By: K... Labeling: Wrong bar code Class II KVK-Tech, Inc.
Dec 11, 2018 Dyural-40 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Eno... Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recall... Class I Asclemed USA Inc. dba Enovachem
Dec 11, 2018 Dyural-80 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Eno... Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recall... Class I Asclemed USA Inc. dba Enovachem
Dec 10, 2018 Advanced Protection Sunscreen spf 30 (Octinoxate 7.5%, Octisalate 5%, Oxybenz... Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients. Class III CBI Laboratories, Inc.
Dec 10, 2018 Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx... Failed dissolution specification -Two additional lots being recalled due to Out-of-Specification ... Class II Dr. Reddy's Laboratories, Inc.
Dec 10, 2018 Options Rx Anti-Oxidant Oil-Free Sunscreeen (Octinoxate 7.5%, Octisalate 5%, ... Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients. Class III CBI Laboratories, Inc.
Dec 10, 2018 Monsel's (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as o... Superpotent Drug: contains higher levels of Iron than labeled. Class II Gordon Laboratories
Dec 7, 2018 Soothe & Cool Protect Moisture Guard Skin Protectant (petrolatum 59%),3.5 oz ... GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purif... Class II US Pharmaceuticals Inc.
Dec 7, 2018 Medline Remedy Essential Barrier Skin Protectant Ointment (petrolatum 59%) pa... GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purif... Class II US Pharmaceuticals Inc.
Dec 7, 2018 Absorica (Isotretinoin) Capsules 30 mg USP, 30 capsules (3x10 Prescription Pa... Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained dur... Class III Sun Pharmaceutical Industries, Inc.
Dec 7, 2018 Hydrocortisone Cream 1% MS Anti itch Cream with Intensive Healing 2 oz tubes,... GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purif... Class II US Pharmaceuticals Inc.
Dec 6, 2018 Levoxyl (levothyroxine sodium tablets, USP) tablets 112 mcg, 100-count bottle... Superpotent Drug. Class II Pfizer Inc.
Dec 5, 2018 Fentanyl Citrate 2 mcg per mL (200 mcg per 100 mL) and Ropivacaine HCl 0.2% i... Sub-potent Class II Pharmedium Services, LLC
Dec 5, 2018 Fentanyl Citrate 2 mcg per mL (100 mcg per 50 mL) and Ropivacaine HCl 0.1% in... Sub-potent Class II Pharmedium Services, LLC
Dec 4, 2018 Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg, (a) 90-count bottl... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... Class II Mylan Laboratories Limited, (Nashik FDF)
Dec 4, 2018 Amlodipine and Valsartan Tablets, USP 5/160 mg, 30-count bottles, Rx Only, M... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... Class II Mylan Laboratories Limited, (Nashik FDF)
Dec 4, 2018 Amlodipine and Valsartan Tablets, USP 5/320 mg, 30-count bottles, Rx Only, Ma... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... Class II Mylan Laboratories Limited, (Nashik FDF)
Dec 4, 2018 Valsartan and Hydrochlorothiazide Tablets, USP 320/12.5 mg, (a) 90-count bott... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... Class II Mylan Laboratories Limited, (Nashik FDF)
Dec 4, 2018 Valsartan Tablets, USP 40 mg, 30-count bottles, Rx Only, Made in India, Manuf... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... Class II Mylan Laboratories Limited, (Nashik FDF)
Dec 4, 2018 Amlodipine and Valsartan Tablets, USP 10/320 mg, 30-count bottles, Rx Only, M... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... Class II Mylan Laboratories Limited, (Nashik FDF)
Dec 4, 2018 Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg, (a) 90-count bottle... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... Class II Mylan Laboratories Limited, (Nashik FDF)
Dec 4, 2018 Valsartan and Hydrochlorothiazide Tablets, USP 160/25 mg, (a) 90-count bottle... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... Class II Mylan Laboratories Limited, (Nashik FDF)
Dec 4, 2018 Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg, (a) 90-count bott... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... Class II Mylan Laboratories Limited, (Nashik FDF)
Dec 4, 2018 Valsartan Tablets, USP 320 mg, 90-count bottles, Rx Only, Made in India, Manu... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... Class II Mylan Laboratories Limited, (Nashik FDF)
Dec 4, 2018 Valsartan Tablets, USP 80 mg, 90-count bottles, Rx Only, Made in India, Manuf... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... Class II Mylan Laboratories Limited, (Nashik FDF)
Dec 4, 2018 Amlodipine and Valsartan Tablets, USP 10/160 mg, 30-count bottles, Rx Only, M... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... Class II Mylan Laboratories Limited, (Nashik FDF)
Dec 4, 2018 Valsartan Tablets, USP 160 mg, 90-count bottles, Rx Only, Made in India, Manu... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... Class II Mylan Laboratories Limited, (Nashik FDF)
Dec 4, 2018 Estradiol Tablets, USP, 2 mg, 100-count bottle, Rx Only, Distributed by: Epic... Presence of foreign tablet/capsule: A single foreign tablet was found in pharmacy dispensed bottl... Class II Epic Pharma, LLC
Nov 30, 2018 Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, Rx only, 30-count bo... Discoloration: This product is being recalled due to a confirmed pharmacist report that tablets f... Class III Aurobindo Pharma USA Inc.
Nov 30, 2018 NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged... Failed Impurities/Degradation Specifications:Out of specification for impurities. Class III VistaPharm, Inc.
Nov 29, 2018 Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10mL Injectable So... Labeling: Label Error on Declared Strength: Label incorrectly lists concentration as "10 mcg per ... Class I Advanced Pharma Inc.
Nov 27, 2018 Amlodipine and Valsartan Tablets 5 mg/160 mg, (a) 30-count bottles (NDC 0093-... CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... Class II Teva Pharmaceuticals USA

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.