Browse Drug Recalls

6,250 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,250 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 6,250 FDA drug recalls.

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Date	Product	Reason	Class	Firm
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), 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 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), 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	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), 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 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	Phenylephrine2.5%/Tropicamide 1% Ophthalmic Solution, 15mL bottle, Rx only, B...	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	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	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	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	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	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	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	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	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 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	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	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	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	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 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	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	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...
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	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	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	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	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	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...
Jul 14, 2017	NORepinephrine Bitartrate 8 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA P...	Lack of Assurance of Sterility; product has the potential to leak.	Class II	SCA Pharmaceuticals
Jul 14, 2017	Diltiazem 125 mg in 0.9% Sodium Chloride, 1 mg per mL, Total Volume 125 mL Si...	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 HCl 60 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmace...	Lack of Assurance of Sterility; product has the potential to leak.	Class II	SCA Pharmaceuticals
Jul 14, 2017	EPINEPHrine HCl 4 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceut...	Lack of Assurance of Sterility; product has the potential to leak.	Class II	SCA Pharmaceuticals
Jul 14, 2017	fentaNYL 2 mcg/mL + BUPIvacaine 0.125% PF in 0.9% Sodium Chloride 250 mL, Rx ...	Lack of Assurance of Sterility; product has the potential to leak.	Class II	SCA Pharmaceuticals
Jul 14, 2017	ePHEDrine Sulfate 5 mg/mL in NS 5 mL Fill in 12 mL Syringe (25 mg), Rx only, ...	Lack of Assurance of Sterility; product has the potential to leak.	Class II	SCA Pharmaceuticals
Jul 14, 2017	fentaNYL 10 mcg/mL PF in Sodium Chloride 250 mL (Total Dose=2500 mcg), Rx onl...	Lack of Assurance of Sterility; product has the potential to leak.	Class II	SCA Pharmaceuticals
Jul 14, 2017	Norepinephrine Bitartrate 16 mg Added to 0.9% Sodium Chloride 250 mL (64 mcg ...	Lack of Sterility Assurance.	Class II	Cantrell Drug Company
Jul 14, 2017	BUPIVacaine HCl 0.1% PF (From 0.75%) in 0.9% Sodium Chloride, 250 mL Bag, Pre...	Lack of Assurance of Sterility; product has the potential to leak.	Class II	SCA Pharmaceuticals
Jul 14, 2017	Norepinephrine Bitartrate 8 mg Added to 0.9% Sodium Chloride 250 mL (32 mcg p...	Lack of Sterility Assurance.	Class II	Cantrell Drug Company
Jul 14, 2017	fentaNYL 3 mcg/mL + BUPIvacaine 0.1% in 0.9% Sodium Chloride 250 mL, Rx only,...	Lack of Assurance of Sterility; product has the potential to leak.	Class II	SCA Pharmaceuticals
Jul 14, 2017	Glycopyrrolate Injection Solution, 2 mL 0.4 mg/2 mL (0.2 mg/mL) Single-Dose S...	Lack of Sterility Assurance.	Class II	Cantrell Drug Company
Jul 14, 2017	Diltiazem HCl 125 mg in 5% Dextrose 125 mL Single-Dose- Bag, Rx Only, Cantre...	Lack of Sterility Assurance.	Class II	Cantrell Drug Company
Jul 14, 2017	BUPIVacaine HCl 0.125% In 250 mL 0.9% Sodium Chloride Bag, Preservative Free ...	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.