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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

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

6,306 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,306 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 6,306 FDA drug recalls.

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DateProductReasonClassFirm
May 28, 2015 Fluorouracil 4250mg / D5W 285mL, Qty: 1 285 mL Bag, Rx Only. Compounded by: U... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 18, 2015 HYDROXYZINE HYDROCHLORIDE (STERILE WATER) (10ML VIAL) 25MG/ML INJECTABLE, Adv... Lack of Assurance of Sterility Class II Advanced Physician Solutions, Inc.
May 18, 2015 SODIUM TETRADECYL SULFATE (STERILE WATER) (30ML) 3.5% INJECTABLE, Advanced Co... Lack of Assurance of Sterility Class II Advanced Physician Solutions, Inc.
May 18, 2015 HYDROXYPROGESTERONE CAPROATE (OLIVE OIL) 30ML, 10ML VIAL 250MG/ML INJECTABLE,... Lack of Assurance of Sterility Class II Advanced Physician Solutions, Inc.
May 18, 2015 HYDROXYZINE HYDROCHLORIDE (30ML VIAL) (STERILE WATER) 50MG/ML INJECTABLE, Adv... Lack of Assurance of Sterility Class II Advanced Physician Solutions, Inc.
May 18, 2015 ESTRADIOL CYPIONATE (SESAME OIL) (10ML, 30ML VIAL) 40MG/ML INJECTABLE, Advan... Lack of Assurance of Sterility Class II Advanced Physician Solutions, Inc.
May 18, 2015 ESTRADIOL VALERATE (SESAME OIL) 10ML VIAL 10MG/ML INJECTABLE, Advanced Compo... Lack of Assurance of Sterility Class II Advanced Physician Solutions, Inc.
May 18, 2015 NANPYRIDOXINE (STERILE WATER) 30ML 50MG/ML INJECTABLE,Advanced Compounding Ph... Lack of Assurance of Sterility Class II Advanced Physician Solutions, Inc.
May 18, 2015 DMSO (STERILE WATER) SOLUTION -50ML VIAL 50% INJECTABLE, Advanced Compounding... Lack of Assurance of Sterility Class II Advanced Physician Solutions, Inc.
May 18, 2015 NANDROLONE DECANOATE (SESAME OIL) 100ML VIAL 200MG/ML INJECTABLE, Advanced C... Lack of Assurance of Sterility Class II Advanced Physician Solutions, Inc.
May 18, 2015 ESTRADIOL VALERATE (10ML VIAL) SESAME OIL 45MG/ML INJECTABLE, Advanced Compo... Lack of Assurance of Sterility Class II Advanced Physician Solutions, Inc.
May 18, 2015 GLUTATHIONE 200MG/ML (STERILE WATER) (30ML, 50ML VIAL) INJECTABLE, Advanced ... Lack of Assurance of Sterility Class II Advanced Physician Solutions, Inc.
May 18, 2015 SODIUM HYALURONATE (2ML PREFILLED SYRINGE) STERILE WATER 20MG/ML INJECTABLE, ... Lack of Assurance of Sterility Class II Advanced Physician Solutions, Inc.
May 18, 2015 SODIUM HYALURONATE (STERILE WATER) 2.5 ML VIAL 20MG/ML INJECTABLE, Advanced C... Lack of Assurance of Sterility Class II Advanced Physician Solutions, Inc.
May 18, 2015 VITAMIN D3 (OLIVE OIL) (30ML VIAL) 50,000 UNITS/ML INJECTABLE, Advanced Compo... Lack of Assurance of Sterility Class II Advanced Physician Solutions, Inc.
May 18, 2015 SODIUM TETRADECYL (STERILE WATER) 30ML VIAL 2% INJECTABLE, Advanced Compoundi... Lack of Assurance of Sterility Class II Advanced Physician Solutions, Inc.
May 18, 2015 CYANOCOBALAMIN (PARABEN WATER) (10ML, 30ML VIAL) 2000MCG/ML INJECTABLE, Adva... Lack of Assurance of Sterility Class II Advanced Physician Solutions, Inc.
May 18, 2015 ESTRADIOL CYPIONATE (SESAME OIL) 10ML, 30ML VIAL 5MG/ML INJECTABLE, Advanced ... Lack of Assurance of Sterility Class II Advanced Physician Solutions, Inc.
May 18, 2015 GLYCERIN (STERILE WATER) 100ML 71% INJECTABLE, Advanced Compounding Pharmacy,... Lack of Assurance of Sterility Class II Advanced Physician Solutions, Inc.
May 15, 2015 Glutathione INHALATION (PF), solution, 100mg/mL, 4 mL vial, Rx only, dispense... Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Class II Montana Compounding Pharmacy
May 15, 2015 Bimix (PHENT;PAP) (N), solution, (10/300) 1 - 30 mg/mL, injectable, 5ml vial,... Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Class II Montana Compounding Pharmacy
May 15, 2015 Hyaluronidase (RM ONLY), Injectable Solution, 150 U/mL, 10ML vial, Rx only, c... Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Class II Montana Compounding Pharmacy
May 15, 2015 Alprostadil (PFE1), solution, 30 mcg/mL, injectable, 5 mL vial, Rx only, comp... Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Class II Montana Compounding Pharmacy
May 15, 2015 Trimix (PGE1;PHENT;PAP) (N), injectable, (100/10/240) 10UG, 5 mL vial, Rx onl... Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Class II Montana Compounding Pharmacy
May 15, 2015 Alprostadil (PFE1), Solution, 10 mcg/mL, injectable, 5 mL vial, Rx only, comp... Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Class II Montana Compounding Pharmacy
May 15, 2015 Trimix (A;PH,PA) (N), injectable, 160 UG-1.2 mg-9.6/ mg/mL, 2 mL vial, Rx onl... Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Class II Montana Compounding Pharmacy
May 15, 2015 Trimix (A;PH,PA) (N), injectable, 80 UG-0.6 mg-4.8 mg/mL, 1 mL vial, Rx only,... Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Class II Montana Compounding Pharmacy
May 15, 2015 Glutathione INHALATION (PF), NASAL solution, 100 mg/mL, 3 mL vial, Rx only, d... Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Class II Montana Compounding Pharmacy
May 15, 2015 Avastin, solution, 1.25 mg/0.05mL, Injectable, Syringe, Rx only, compounded b... Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Class II Montana Compounding Pharmacy
May 15, 2015 Trimix (PGE1;PHENT;PAP) (N), injectable, (100/10/297) 10UG, 5 mL vial, Rx onl... Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Class II Montana Compounding Pharmacy
May 15, 2015 Alprostadil (PFE1), solution, 20 mcg/mL, injectable, 5 mL vial, Rx only, comp... Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Class II Montana Compounding Pharmacy
Apr 7, 2015 0.9% Sodium Chloride Injection, USP, 100 mL ADD-Vantage Unit, Rx only, Manufa... Lack of Sterility Assurance: The product has the potential to leak at the administrative port. Class II Hospira Inc.
Mar 23, 2015 0.9% Sodium Chloride Injection, USP, 50 mL, VIAFLEX Plastic Container Multi P... Lack of Assurance of Sterility; increased complaints received for leaks Class II Baxter Healthcare Corp
Mar 23, 2015 Clinimix E 5/20 sulfite-free (5% amino-acid with electrolytes in 20% dextrose... Lack of Assurance of Sterility; increased complaints received for leaks Class II Baxter Healthcare Corp
Mar 18, 2015 5% Dextrose Injection, USP, 1000mL in VIAFLEX Plastic Container, Rx only, Man... Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which ma... Class II Baxter Healthcare Corp.
Mar 18, 2015 0.9% Sodium Chloride Injection, USP, 500 mL in VIAFLEX Plastic Container, Rx ... Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which ma... Class II Baxter Healthcare Corp.
Mar 17, 2015 Papaverine/phentolamine/prostaglandin 16/0.5/0.005 mg/mL Injection, Fallon We... Lack of assurance of sterility Class II Fallon Wellness Pharmacy, L.L.C.
Mar 17, 2015 Hydroxocobalamin 1) 1000mcg/mL, 2) 5mg/0.5mL, 3) 5000mcg/0.2mL injection, Fal... Lack of assurance of sterility Class II Fallon Wellness Pharmacy, L.L.C.
Mar 17, 2015 Prostaglandin Rx, dispensed in 5 ml vials: 1) 10 mcg/mL Injection, 2) 22.5 mc... Lack of assurance of sterility Class II Fallon Wellness Pharmacy, L.L.C.
Mar 17, 2015 Methylcobalamin/B-Complex Rx 2.5/103 mg/mL Injection, Fallon Wellness Pharmac... Lack of assurance of sterility Class II Fallon Wellness Pharmacy, L.L.C.
Mar 17, 2015 Methylcobolamin 1) 6500 mcg/0.26mL, 2) 1000 mcg/0.08mL, 3) 5000mcg/mL, 4) 300... Lack of assurance of sterility Class II Fallon Wellness Pharmacy, L.L.C.
Mar 17, 2015 Papaverine/phentolamine/prostaglandin 30/1/0.02 mg/mL Injection, Fallon Welln... Lack of assurance of sterility Class II Fallon Wellness Pharmacy, L.L.C.
Mar 17, 2015 Papaverine/phentolamine/prostaglandin 30/1/0.01mg/mL Injection, Fallon Wellne... Lack of assurance of sterility Class II Fallon Wellness Pharmacy, L.L.C.
Mar 17, 2015 Papaverine/phentolamine/prostaglandin 30/1/0.025 mg/mL Injection, Fallon Well... Lack of assurance of sterility Class II Fallon Wellness Pharmacy, L.L.C.
Mar 17, 2015 Papaverine/phentolamine/prostaglandin 30/4/0.04 mg/mL Injection, Fallon Welln... Lack of assurance of sterility Class II Fallon Wellness Pharmacy, L.L.C.
Mar 17, 2015 Methylcobalamin/Hydroxocobalamin Rx 3.125/3.125 mg/0.5 mL Injection, Fallon W... Lack of assurance of sterility Class II Fallon Wellness Pharmacy, L.L.C.
Mar 11, 2015 LACTATED RINGER'S IRRIGATION, USP, 3000 mL flexible container bag, Rx Only, M... Non-Sterility: Confirmed customer report of dark, fibrous particulates floating within the soluti... Class I Hospira Inc.
Mar 9, 2015 Fomepizole Injection, 1.5 g/1.5 mL (1 g/mL), For Intravenous Infusion only, R... Lack of Assurance of Sterility. A recent FDA inspection reported GMP violations potentially impac... Class II Navinta LLC
Mar 5, 2015 5% DEXTROSE Injection, USP, 250 mL ADD-Vantage Unit bag (NDC 0409-7100-02), U... Lack of Assurance of Sterility: there is a potential for solution to leak at the administrative p... Class II Hospira Inc.
Feb 25, 2015 Colistimethate for Injection USP, 150 mg per vial, Rx Only, Manufactured by:... Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with qu... Class II Heritage Pharmaceuticals, 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.