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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

6,274 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
May 31, 2018 0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake ... Lack of assurance of sterility: Bags have potential to leak. Class II ICU Medical Inc
May 31, 2018 0.45% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake... Lack of assurance of sterility: Bags have potential to leak. Class II ICU Medical Inc
May 17, 2018 MIC "B" COMBO LIPOTROPIC 50 ml. Packaged in a 50ml MDV vial. Compounded Guard... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Morphine Sulfate 1 mg/mL CADD 25 mL . RX only. Packaged in a CADD 25 ml. Comp... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Ropivacaine HCl 2 mg/mL 550 mL. Rx Only. Packaged in a ON-Q Pump. Compounded ... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Medroxyprogesterone 150 mg/mL 5ml. Rx Only. Packaged in 5 mL vials. Compounde... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL vials. Compounded G... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Lidocaine 3% 10 ml. Rx Only. Packaged in 10 mL syringes. Compounded Guardian ... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Ascorbic Acid 500 mg/mL 500 mL TPN. Rx Only. Packaged in 500 ml bag. Compound... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Methylene Blue 10 mg/mL 1ml. Packaged in 1 mL syringes. Compounded Guardian P... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Methylcobalamin 1000 mcg/mL 100 mL. RX Only. Packaged in 100ml MDV vials. Com... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Magnesium Sulfate 200 mg/mL, 100ml. Rx. Only. Packaged in 100 mL MDV vials. C... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Phenol 6% with Glycerin Inj 10 ml. Packaged in 10 ml vials. Compounded Guardi... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Ropivacaine HCl 2 mg/mL 750 mL. Rx Only. Packaged in a ON-Q Pump. Compounded ... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Fentanyl Citrate 50 mcg/mL 2ml. Rx Only. Packaged in 2 mL syringes. Compounde... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 B-Complex Rx only. packaged in a) 100 mL bag b) 100 ml MDV vial. Compounded G... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Ascorbic Acid 500 mg/mL 100 mL vial. Rx Only. Packaged in a 100 ml vial. Comp... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Cefazolin 2 Gm/20 mL 20 ml. Rx Only. Packaged in 20 mL syringes. Compounded G... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Glycopyrrolate 0.2 mg/mL 2ml. Rx Only. Packaged in 2 mL syringes. Compounded ... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Glutathione 200 mg/mL 100 ml. Rx Only. Packaged in 50ml MDV vials. Compounded... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 EDTA Disodium 30 mg/mL PF. Rx Only. Packaged in 1 mL pre filled syringe. Comp... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Glutathione 200 mg/mL 50 ml MDV. Rx Only. Packaged in 50 mL vials. Compounde... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Ropivacaine HCl 2 mg/mL 400 mL. Rx Only. Packaged in a ON-Q Pump. Compounded ... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL syringes. Refridger... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Glutathione 200 mg/mL 100ml. Rx Only. Packaged in 100 mL MDV vials. Compounde... Lack of sterility assurance. Class II Guardian Pharmacy Services
Apr 26, 2018 Macroaggregated albumin (MAA) kit (for the preparation of Tc99m MAA), Aggrega... Lack of Assurance of Sterility Class II Coast Quality Pharmacy LLC
Apr 24, 2018 Methionine 25mg/Inositol 50mg/Choline 50mg/Cyanocobalamin 1mg/ml, Sterile inj... Lack of assurance of sterility: Upon review of recent 3rd party environmental certification docum... Class II Vitalab Pharmacy, Inc
Apr 24, 2018 Alprostadil 20 mcg/mL, Sterile injectable, Vitalab Pharmacy, Inc Lack of assurance of sterility: Upon review of recent 3rd party environmental certification docum... Class II Vitalab Pharmacy, Inc
Apr 24, 2018 Papaverine 30mg/Phentolamine 1.5mg/Prostaglandin 50mcg/mL, sterile injectable... Lack of assurance of sterility: Upon review of recent 3rd party environmental certification docum... Class II Vitalab Pharmacy, Inc
Apr 24, 2018 Methylcobalamin for injection, 1mg/mL and 10 mg/mL, Sterile injectable, Vital... Lack of assurance of sterility: Upon review of recent 3rd party environmental certification docum... Class II Vitalab Pharmacy, Inc
Apr 24, 2018 Papaverine 30mg/Phentolamine 2mg/Prostaglandin 20mcg/mL, Papaverine 30mg/Phe... Lack of assurance of sterility: Upon review of recent 3rd party environmental certification docum... Class II Vitalab Pharmacy, Inc
Apr 24, 2018 Papaverine 9mg/Phentolamine 1mg/Atropine 0.1mg/Prostaglandinl 10mcg/ml, steri... Lack of assurance of sterility: Upon review of recent 3rd party environmental certification docum... Class II Vitalab Pharmacy, Inc
Apr 11, 2018 Morphine Sulfate 2 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syri... Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of sub... Class II Premier Pharmacy Labs Inc
Apr 11, 2018 NEOstigmine Methylsulfate (1 mg/mL) 3mg per 3mL. 3mL Single Dose Syringe. Pre... Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of sub... Class II Premier Pharmacy Labs Inc
Apr 11, 2018 Morphine Sulfate 4 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syri... Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of sub... Class II Premier Pharmacy Labs Inc
Apr 11, 2018 Hydromorphone HCl 1 mg/mL PF INJ. 1mL in a 3mL Sterile Single-Dose Syringe. ... Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of sub... Class II Premier Pharmacy Labs Inc
Mar 27, 2018 Levetiracetam in 0.82% Sodium Chloride Injection, 500 mg per 100 mL (5 mg/mL)... Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found betwee... Class II AuroMedics Pharma LLC
Mar 27, 2018 Levofloxacin in 5% Dextrose Injection, 500 mg Levofloxacin (5 mg/mL) in 100 m... Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found betwee... Class II AuroMedics Pharma LLC
Mar 27, 2018 Levofloxacin in 5% Dextrose Injection, 750 mg Levofloxacin (5 mg/mL) in 150 m... Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found betwee... Class II AuroMedics Pharma LLC
Mar 27, 2018 Linezolid Injection 600 mg per 300 mL (2 mg/mL) For Intravenous Administratio... Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found betwee... Class II AuroMedics Pharma LLC
Mar 27, 2018 Levofloxacin in 5% Dextrose Injection, 250 mg Levofloxacin (5 mg/mL) in 50 mL... Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found betwee... Class II AuroMedics Pharma LLC
Mar 27, 2018 Levetiracetam in 0.75% Sodium Chloride Injection, 1000 mg per 100 mL (10 mg/m... Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found betwee... Class II AuroMedics Pharma LLC
Mar 27, 2018 Levetiracetam in 0.54% Sodium Chloride Injection, 1,500 mg per 100 mL (15 mg/... Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found betwee... Class II AuroMedics Pharma LLC
Mar 22, 2018 Methionine 25mg/Inositol 50mg/Choline 50mg/ B12 1mg, 50 mL amber vial, Rx onl... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Estradiol 40 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharma... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Glutathione 200mg/mL, 10mL amber vial, Rx only, Partell Specialty Pharmacy, 5... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Testosterone 200 mg pellet packaged in amber vial, Rx only, Partell Specialty... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Ascorbic Acid (Tapioca) 500 mg/mL, 50 mL amber vial, Rx only, Partell Speci... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 MVI-7 (B1-100mg/B3-100mg, B5-252 mg, B6-102mg, Vit C-2500 mg, B12-10mg, Mag-1... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 TM #3 (ALP10/PAPAV12/PHENT1), 3 mL amber vial, Rx only, Partell Specialty Pha... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy

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.