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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

6,306 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
Oct 10, 2017 Midazolam HCL 100 mg (1mg/mL) 100 mL Cassette in 0.9% Sodium Chloride, Rx Onl... Lack of Assurance of Sterility. Class II Banner Pharmacy Services, LLC
Oct 10, 2017 Hydromorphone HCl 10 mg (0.2mg/ml) 50 mL syringes in 0.9% Sodium Chloride, Rx... Lack of Assurance of Sterility. Class II Banner Pharmacy Services, LLC
Oct 10, 2017 Ropivacaine HCL (PF) 0.2% (2mg/mL) 100 mL Cassette Rx Only Banner Health Com... Lack of Assurance of Sterility. Class II Banner Pharmacy Services, LLC
Oct 10, 2017 Succinylcholine 200 mg/10 mL Syringe, Rx Only, Banner Health Compounding Phar... Lack of Assurance of Sterility. Class II Banner Pharmacy Services, LLC
Sep 25, 2017 methylPREDNIsolone ACETATE, 40 MG/ML INJECTION SUSPENSION, 10 ML Vial, RXQ Co... Lack of Assurance of Sterility; autoclave parameters were not correct for one of two autoclaves u... Class II RXQ Compounding LLC
Sep 20, 2017 Symbio Muc Eye, 0.17 fl.oz. 5mL bottles, Manufactured for and distributed in ... Lack of Assurance of Sterility Class II Deserving Health International Corp
Sep 5, 2017 Alcohol Prep Pads (Isopropyl Alcohol USP 70% v/v), 100 Individual Pads, Steri... Lack of Assurance of Sterility and cGMP Deviations Class II Simple Diagnostics, Inc.
Sep 5, 2017 Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 32 oz.... Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. Class II Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi...
Sep 5, 2017 Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 1 oz. ... Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. Class II Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi...
Sep 5, 2017 Activase (alteplase), 100 mg (58 million IU), Lyophilized vial, packaged with... Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials. Class I Genentech, Inc.
Sep 5, 2017 Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 16 oz.... Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. Class II Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi...
Sep 5, 2017 Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 4 oz. ... Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. Class II Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi...
Sep 1, 2017 Sterile Water for Injection, USP Single Dose 100 mL vials, Rx only, Manufactu... Non-Sterility: cracked or chipped glass at the neck of Sterile Water for Injection vials. Class II Pfizer Inc.
Aug 22, 2017 Levophed (norepinephrine bitartrate) injection, USP, 4 mg/4 mL (1mg/mL), 4mL ... Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used... Class II Pfizer Inc.
Aug 22, 2017 HYDROmorphone HCl Injection, USP, 2 mg/mL, 1mL Single-use vial, packaged in c... Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used... Class II Pfizer Inc.
Aug 17, 2017 All Sterile Products within expiry Lack of Assurance of Sterility . Class II Vital Rx, Inc. dba Atlantic Pharmacy and Compou...
Aug 15, 2017 Sodium Bicarbonate 8.4%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave... Lack of Assurance of Sterility. Class II Bella Pharmaceuticals, Inc.
Aug 15, 2017 B-Complex, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL... Lack of Assurance of Sterility. Class II Bella Pharmaceuticals, Inc.
Aug 15, 2017 Magnesium Chloride 200mg, 30m L vials, Rx only, Bella Pharma 3101 W. Devon Av... Lack of Assurance of Sterility. Class II Bella Pharmaceuticals, Inc.
Aug 15, 2017 Fluorescein Sodium, 5mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chic... Lack of Assurance of Sterility. Class II Bella Pharmaceuticals, Inc.
Aug 15, 2017 G.A.C 25/100/250mg, 30 mL Vials, Rx only, Bella Pharma 3101 W. Devon Ave., Ch... Lack of Assurance of Sterility. Class II Bella Pharmaceuticals, Inc.
Aug 15, 2017 Mannitol 20%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago,... Lack of Assurance of Sterility. Class II Bella Pharmaceuticals, Inc.
Aug 15, 2017 Lidocaine Ophthalmic Gel 3.5%, 15mL bottles, Rx only, Bella Pharma 3101 W. De... Lack of Assurance of Sterility. Class II Bella Pharmaceuticals, Inc.
Aug 15, 2017 Methylcobalamin 10mg, (10mg/ml), 30 mL vials, Rx only, Bella Pharma 3101 W. D... Lack of Assurance of Sterility. Class II Bella Pharmaceuticals, Inc.
Aug 15, 2017 MIC 25/50/50, 30mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, ... Lack of Assurance of Sterility. Class II Bella Pharmaceuticals, Inc.
Aug 15, 2017 Phenylephrine2.5%/Tropicamide 1% Ophthalmic Solution, 15mL bottle, Rx only, B... Lack of Assurance of Sterility. Class II Bella Pharmaceuticals, Inc.
Aug 15, 2017 L-Glutamine 100mg, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chi... Lack of Assurance of Sterility. Class II Bella Pharmaceuticals, Inc.
Aug 15, 2017 BevaDex (bevacizumab) 0.06mL Prefilled 32 g (1.25mg/1mg) Syringes, Rx only, ... Lack of Assurance of Sterility. Class II Bella Pharmaceuticals, Inc.
Aug 15, 2017 Bevacizumab Prefilled 30g and 31 gram 1.25mg/0.05mL Syringes, Rx only, Bella ... Lack of Assurance of Sterility. Class II Bella Pharmaceuticals, Inc.
Aug 15, 2017 Methylcobalamin 10mg, (1mg/ml), 30 mL vials, Rx only, Bella Pharma 3101 W. De... Lack of Assurance of Sterility. Class II Bella Pharmaceuticals, Inc.
Aug 15, 2017 Calcium chloride 10%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., ... Lack of Assurance of Sterility. Class II Bella Pharmaceuticals, Inc.
Aug 15, 2017 PF-Glutathione 200mg/ml, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave... Lack of Assurance of Sterility. Class II Bella Pharmaceuticals, Inc.
Aug 10, 2017 Fentanyl 2 mcg/mL and ropivacaine 0.2% in 0.9% Sodium Chloride 150 mL, 150 mL... Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufac... Class II SSM Health Care St. Louis DBA SSM St. Clare Hea...
Aug 10, 2017 Norepinephrine 8 mg in dextrose 5% 250 mL, 250mL IV Bag, Concentration: 0.032... Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufac... Class II SSM Health Care St. Louis DBA SSM St. Clare Hea...
Aug 10, 2017 Oxytocin 30 units in 0.9% Sodium Chloride 500 mL, 500 mL IV Bag, Concentratio... Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufac... Class II SSM Health Care St. Louis DBA SSM St. Clare Hea...
Aug 10, 2017 Succinylcholine chloride 100 mg in 5 mL syringe, Concentration: 20 mg/mL. Th... Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufac... Class II SSM Health Care St. Louis DBA SSM St. Clare Hea...
Aug 10, 2017 Morphine 50 mg in 0.9% Sodium Chloride 5 mL PCA, 50 mL Cartridge, Concentrati... Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufac... Class II SSM Health Care St. Louis DBA SSM St. Clare Hea...
Aug 10, 2017 Amiodarone 900 mg in dextrose 5% 500 mL, 500 mL bag, Concentration: 1.8 mg/mL... Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufac... Class II SSM Health Care St. Louis DBA SSM St. Clare Hea...
Aug 10, 2017 Neostigmine Methylsulfate 5 mg/5 mL, 5 mL Syringe, Concentration: 1 mg/mL. T... Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufac... Class II SSM Health Care St. Louis DBA SSM St. Clare Hea...
Aug 10, 2017 HYDROmorphone 10 mg in 0.9% Sodium Chloride 50 mL PCA, 50 mL Cartridge, Conce... Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufac... Class II SSM Health Care St. Louis DBA SSM St. Clare Hea...
Aug 10, 2017 Fentanyl 10 mcg in 0.9% Sodium Chloride 1 mL, 1 mL Vial, Concentration: 10 mc... Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufac... Class II SSM Health Care St. Louis DBA SSM St. Clare Hea...
Aug 10, 2017 Phenylephrine 1000 mcg in 0.9% Sodium Chloride 10 mL, 10 mL syringe, Concentr... Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufac... Class II SSM Health Care St. Louis DBA SSM St. Clare Hea...
Jul 14, 2017 Glycopyrrolate Injection Solution, 1 mL 0.2 mg/1 mL (0.2 mg/mL) Single-Dose S... Lack of Sterility Assurance. Class II Cantrell Drug Company
Jul 14, 2017 NORepinephrine 4 mg in 0.9% Sodium Chloride 250 mL from Stock, Rx only, SCA P... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 14, 2017 MAGNESIUM Sulfate 4 g added to 100 mL 0.9% Sodium Chloride, Total Approximate... Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have t... Class II SCA Pharmaceuticals
Jul 14, 2017 PHENYLephrine 10 mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmace... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 14, 2017 Rocuronium Bromide Injection Solution 5 mL, 50 mg/5 mL (10 mg/mL) Single-Dose... Lack of Sterility Assurance. Class II Cantrell Drug Company
Jul 14, 2017 PHENYLephrine 100 mg in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmac... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 14, 2017 PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride, (Final Concentration = 0.1 m... Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have t... Class II SCA Pharmaceuticals
Jul 14, 2017 Potassium Chloride 40 meq Added to Sodium Chloride 0.9% 250 mL, Rx only, SCA ... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals

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.