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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

6,274 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,274 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 6,274 FDA drug recalls.

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DateProductReasonClassFirm
Sep 18, 2015 Tobramycin 120MG, Packaged in 150ML Homepumps, Rx Only. SENTARA HOME HEALTH S... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 MYCAMINE (micafungin sodium) 150MG, Packaged in 150ML Homepumps, Rx Only. SEN... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 ZOSYN (pipericillin/tazobactam) in NS, Packaged as a) 3.375GM in 50ML Homepum... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 VANCOMYCIN HCL, Packaged as: a) 600MG in 120ML Homepumps, b) 750MG in 150ML H... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 Cancidas (caspofungin acetate) 58.4MG in NS, Packaged in 116.8ML Homepumps, R... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 SOLUMEDROL (methylprednisolone succinate) 1GM in NS, Packaged in 100ML Homepu... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 DOBUTAMINE HCL in D5W, Packaged as a) 240MG in 60ML Homepumps and b) 1520MG i... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 GENTAMICIN, Packaged as a) 70MG in 70ML Homepumps, b) 80MG in 80ML Homepumps,... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 INTRALIPID (fat emulsion), Packaged in a) 27ML Homepumps, b) 125ML Homepumps,... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 Parenteral Amino Acid Infusion 10%, Packaged in a) 780ML Homepumps, b) 1000ML... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 MEROPENEM in NS, Packaged as a) 1000MG in 250ML Homepumps, and b) 2GM in 100M... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 ONDANSETRON HCL 8MG, Packaged in 100ML Homepumps. Rx Only. SENTARA HOME HEALT... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 CEFEPIME, Packaged a) 1GM in 50ML Homepumps, b) 2GM in 100ML Homepumps, and c... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 POTASSIUM CHLORIDE in D 5 1/2NS, Packaged in a) 40 mEq KCL/LITER 1000ML Homep... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 FLUCONAZOLE IN NACL 400MG in NS, Packaged in 200ML Homepumps, Rx Only. SENTAR... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 CUBICIN (daptomycin) in NS, Packaged as a) 350MG in 7ML Syringes, b)365MG in ... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 CEFTRIAXONE in NS, Packaged as a) 1GM in 50ML Homepumps, b) 2GM in 100ML Home... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 MORPHINE 10MG/ML in NS, Packaged in a) 150ML Homepumps and b) 250ML Homepumps... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 12, 2015 HCG/B12 (5,000 units, 0.6 mg) 5 mL, Multi-Dose Vial, For IM or SC Injection, ... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Morphine PF (2 mg/2 mL), 2 mL Single Use Vial, For IV or IM Administration, R... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Tropicamide 0.5%/ Phenylephrine 5%, 2 mL Dropper Bottle For Topical Ophthalm... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Phenylephrine 1.5%/ Lidocaine 1%, 1 mL Single Use Vial, For Intracameral Inje... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Dex Combo (Dexamethasone acetate 8mg/mL, dexamethasone sodium phosphate USP, ... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Alprostadil (PGE-1), 5 mL (40 mcg/mL) in 10 mL Multi-Dose Vial, Rx only, Comp... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Triamcinolone diacetate USP (40 mg/mL), 30 mL Multi-Dose Vial, For IM & Regio... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Cyclo/PE/Trop PF (1%/2.5%/1%), 3 mL dropper bottle, For topical ophthalmic us... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Triamcinolone/Lidocaine (40 mg/1%/mL), 10 mL Multidose Vial, For IM & Regiona... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Glycopyrrolate USP ( 1 mg/5 mL), 5 mL Single Use syringe, For IM or IV Injec... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Betamethasone SP, 2 mL (6 mg/mL),10 mL Multi-Dose Vial, For IM & Regional Inj... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Voriconazole Solution (1%(10 mg/mL), 15 mL dropper bottle; For Topical Ophtha... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Cyclo/PE/Tropic/Ketor (1%/2.5%/1%/0.5%), 10 mL Opthalmic dropper bottle, For ... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 MedroxyPROGESTERone/Lidocaine (150 mg/mL/1%) 10 mL Multi-Dose Vial, For IM In... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Phenylephrine PF (1 mg/10 mL), 10 mL Single Use Syringe, For IV Use, Rx only,... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Lincomycin/Lidocaine (300 mg/1%/mL), 10 mL Multi-Dose Vial, For IV Injection ... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 L-Cysteine PF (50 mg/mL), 10 mL Single Dose Vial, For IV Use After Dilution, ... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Vancomycin Ophthalmic PF 0.5 mL (5 mg/0.5 mL (10 mg/mL), 1 mL syringe, For To... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Triamcinolone acetonide, USP (50 mg/mL), 10 mL Multi-Dose Vial, For IM & Regi... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Bi-Mix (Papaverine 30 mg/mL, Phentolamine 1 mg/mL), 5 mL Multi-Dose Vial, Rx ... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Betamethasone Combo 10 mL (7 mg/mL), 10 mL Multi-Dose Vial,for IM & Regional ... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Tri-Mix 30/1/10 (papaverine HCL USP 30 mg/ phentolamine mesylate USP 1 mg/ al... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Phenylephrine PF Sterile Solution (2.5%), 3 mL Single Use Ophthalmic Dropper ... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Brompheniramine Maleate (10 mg/mL), 10 mL Multi-Dose Vial, Rx only, Compounde... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 MIC Combo (Methionine 25 mg/mL, Inositol 50 mg/mL, Choline chloride 50 mg/mL,... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 ePHEDrine Sulfate PF (50 mg/10 mL), 10 mL Single-Use Syringe, For IV or IM Us... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 MethylPREDNISolone (100 mg/mL) 10 mL Multi-Dose Vial, For IM & Regional Injec... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Trace Elements-4 (Zinc Sulfate heptahydrate 4.39 mg, Cupric Sulfate pentahydr... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Neostigmine (5 mg/5 mL), 5 mL Single Use Syringe, For IM, SC or Slow IV Inje... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Pilocarpine (1/16%) Ophthalmic, 15 mL dropper bottle, Rx only, Compounded by ... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Prednisolone Sodium Phosphate PF Solution (1%) in 15 mL dropper bottle; For T... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Dapiprazole (Diluent+Powder) 0.5% in 5 mL vial, For topical ophthalmic use, ... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding 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.