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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Showing 12,701–12,720 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

Gent 80 mg/Liter Nasal, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938

by Western Drug

Reason
Lack of Assurance of Sterility
Recall initiated
October 19, 2015
Reported by FDA
December 9, 2015
Distribution
Nationwide in US: Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah

View recall →

Drug Recall Terminated Historical recordClass II

Furosemide 20 mg/mL svn Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938

by Western Drug

Reason
Lack of Assurance of Sterility
Recall initiated
October 19, 2015
Reported by FDA
December 9, 2015
Distribution
Nationwide in US: Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah

View recall →

Drug Recall Terminated Historical recordClass II

Folic Acid Injection 5 mg/mL,10 mg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938

by Western Drug

Reason
Lack of Assurance of Sterility
Recall initiated
October 19, 2015
Reported by FDA
December 9, 2015
Distribution
Nationwide in US: Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah

View recall →

Drug Recall Terminated Historical recordClass II

Depo-Testadiol 10/5mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938

by Western Drug

Reason
Lack of Assurance of Sterility
Recall initiated
October 19, 2015
Reported by FDA
December 9, 2015
Distribution
Nationwide in US: Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah

View recall →

Drug Recall Terminated Historical recordClass II

Dep-Estradiol 10 mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938

by Western Drug

Reason
Lack of Assurance of Sterility
Recall initiated
October 19, 2015
Reported by FDA
December 9, 2015
Distribution
Nationwide in US: Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah

View recall →

Drug Recall Terminated Historical recordClass II

Cyclosporine 1% Opth Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938

by Western Drug

Reason
Lack of Assurance of Sterility
Recall initiated
October 19, 2015
Reported by FDA
December 9, 2015
Distribution
Nationwide in US: Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah

View recall →

Drug Recall Terminated Historical recordClass II

Butor/Nal/Hydro Nasal Susp, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938

by Western Drug

Reason
Lack of Assurance of Sterility
Recall initiated
October 19, 2015
Reported by FDA
December 9, 2015
Distribution
Nationwide in US: Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah

View recall →

Drug Recall Terminated Historical recordClass II

Boric Acid 1% Ear Drop, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938

by Western Drug

Reason
Lack of Assurance of Sterility
Recall initiated
October 19, 2015
Reported by FDA
December 9, 2015
Distribution
Nationwide in US: Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah

View recall →

Drug Recall Terminated Historical recordClass II

Bladder Mixture Prep, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938

by Western Drug

Reason
Lack of Assurance of Sterility
Recall initiated
October 19, 2015
Reported by FDA
December 9, 2015
Distribution
Nationwide in US: Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah

View recall →

Drug Recall Terminated Historical recordClass II

B-12 1000/B6 1000 mcg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938

by Western Drug

Reason
Lack of Assurance of Sterility
Recall initiated
October 19, 2015
Reported by FDA
December 9, 2015
Distribution
Nationwide in US: Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah

View recall →

Drug Recall Terminated Historical recordClass II

AMP50/B121MG Complex Mix/ML Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938

by Western Drug

Reason
Lack of Assurance of Sterility
Recall initiated
October 19, 2015
Reported by FDA
December 9, 2015
Distribution
Nationwide in US: Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah

View recall →

Drug Recall Terminated Historical recordClass II

Ace-Promazine 10 mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938

by Western Drug

Reason
Lack of Assurance of Sterility
Recall initiated
October 19, 2015
Reported by FDA
December 9, 2015
Distribution
Nationwide in US: Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah

View recall →

Drug Recall Terminated Historical recordClass II

Prostin Injection 10 mcg/mL, 25 mcg/mL, 50 mcg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938

by Western Drug

Reason
Lack of Assurance of Sterility
Recall initiated
October 19, 2015
Reported by FDA
December 9, 2015
Distribution
Nationwide in US: Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah

View recall →

Drug Recall Terminated Historical recordClass II

Polyethylene Glycol 3350-GRX Powder 100% jars a) 8.4 oz (250 g) (NDC 54162-335-02), b) Net wt. 16.9 oz (500 g) (NDC 54162-335-05), Distributed by: Geritrex Corporation, Mount Vernon, NY 10550

by Geritrex Corp

Reason
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Recall initiated
October 27, 2015
Reported by FDA
December 9, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

GRx HiCort 25 (hydrocortisone acetate 25 mg) Suppositories, 12-count box, Rx only, Distributed by Geritrex Corporation Mount Vernon, NY 10550, NDC 54162-015-12

by Geritrex Corp

Reason
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Recall initiated
October 27, 2015
Reported by FDA
December 9, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Carbo-O-Philic 40 Gel 40% (Urea) NET WT tube, .5 oz (15 g), Rx Only For topical use only, Distributed byGeritrex Corporation 144, Mount Vernon, NY 10550, NDC 54162-016-15

by Geritrex Corp

Reason
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Recall initiated
October 27, 2015
Reported by FDA
December 9, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Carbo-O-Philic 40 Cream 40% (Urea) tubes, a) 3 oz (85 g) (NDC 54162-640-03) , b) 7 oz (200 g) (NDC 54162-640-07), Rx Only For topical use only, Distributed by Geritrex Corporation, East Mount Vernon, NY 10550

by Geritrex Corp

Reason
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Recall initiated
October 27, 2015
Reported by FDA
December 9, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator Refills (Racepinephrine USP 11.25 mg), 30 individual foil wrapped vials per carton, Manufactured By: nephron pharmaceuticals corporation, Orlando, FL --- NDC 0487-2784-01

by Nephron Pharmaceuticals Corp.

Reason
Discoloration
Recall initiated
August 21, 2015
Reported by FDA
December 9, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator, Starter Kit (Racepinephrine 11.25 mg) 10 individual foil wrapped vials with 1 EZ Breathe Atomizer per carton, Manufactured By: nephron pharmaceuticals corporation, Orlando, FL --- NDC 0487-2784-10

by Nephron Pharmaceuticals Corp.

Reason
Discoloration
Recall initiated
August 21, 2015
Reported by FDA
December 9, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Testosterone USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 25 mg (NDC 69761-125-01), 37.5 mg (NDC 69761-137-01), 50 mg (NDC 69761-150-01), 87.5 mg (NDC: 69761-187-01), 100 mg (NDC 69761-110-01), 200 mg (NDC 69761-120-01), Rx only, Compounded by Qualgen, Edmond, Oklahoma 73013

by Qualgen

Reason
Lack of Assurance of Sterility: The firm is recalling all sterile preparations within expiry due to deficient practices which may have an impact on sterility assurance.
Recall initiated
October 9, 2015
Reported by FDA
December 2, 2015
Distribution
Nationwide

View recall →

Data last updated:

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.