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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 6,421–6,440 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass II

Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate Injection 20MCG/30MG/1MG/ML Injectable, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0545-2

by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Reason
Lack of Assurance of Sterility
Recall initiated
January 15, 2020
Reported by FDA
March 11, 2020
Distribution
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

View recall →

Drug Recall Terminated Historical recordClass II

Alprostadil (prostaglandin E1) 80 MCG/ML Injectable, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0543-2

by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Reason
Lack of Assurance of Sterility
Recall initiated
January 15, 2020
Reported by FDA
March 11, 2020
Distribution
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

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Drug Recall Terminated Historical recordClass II

Alprostadil (prostaglandin E1)150 MCG/ML Injectable, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0538-2

by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Reason
Lack of Assurance of Sterility
Recall initiated
January 15, 2020
Reported by FDA
March 11, 2020
Distribution
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

View recall →

Drug Recall Terminated Historical recordClass II

Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection, 60 mcg/30 mg/2 mg/0.15mg/ml, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0550-2

by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Reason
Lack of Assurance of Sterility
Recall initiated
January 15, 2020
Reported by FDA
March 11, 2020
Distribution
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

View recall →

Drug Recall Terminated Historical recordClass II

Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection, 40 mcg/25 mg/0.5mg/0.01mg/ml, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0549-2

by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Reason
Lack of Assurance of Sterility
Recall initiated
January 15, 2020
Reported by FDA
March 11, 2020
Distribution
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

View recall →

Drug Recall Terminated Historical recordClass II

Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection, 18 mcg/1.8mg/0.2mg/0.02mg/mL, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0547-2

by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Reason
Lack of Assurance of Sterility
Recall initiated
January 15, 2020
Reported by FDA
March 11, 2020
Distribution
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

View recall →

Drug Recall Terminated Historical recordClass III

Discount Drug Mart, Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg /Antihistamine, Indoor/Outdoor Allergies, 24 Hour, a) 30 tablets per bottle, NDC 53943-192-04, UPC Code 0-93351-03069-7; b) 45 tablets per bottle, NDC 53943-192-06, UPC Code 0-93351-03070-3, Distributed by: Drug Mart -Food Fair, 211 Commerce Drive, Medina, OH 44256.

by AAA Pharmaceutical, Inc.

Reason
Labeling: Incorrect or Missing Lot and/or Expiration date.
Recall initiated
February 14, 2020
Reported by FDA
March 11, 2020
Distribution
Ohio

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Drug Recall Terminated Historical recordClass II

Desoximetasone Topical Spray, 0.25%, 2.5 mg desoximetasone, 100 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Baltimore, MD

by Lupin Pharmaceuticals Inc.

Reason
Failed Impurities/Degradation Specification; high out of specification results observed
Recall initiated
February 19, 2020
Reported by FDA
March 11, 2020
Distribution
Product was distributed throughout the United States.

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Drug Recall Terminated Historical recordClass II

Mesalamine Delayed-Release Tablets, USP, 1.2 gram, 120-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; NDC 0591-2245-22.

by Teva Pharmaceuticals USA

Reason
Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing.
Recall initiated
February 20, 2020
Reported by FDA
March 11, 2020
Distribution
Nationwide in the USA.

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Drug Recall Terminated Historical recordClass III

Zoledronic Acid Injection 5 mg/100 mL (0.05 mg/mL), Solution for Intravenous Infusion, Sterile Solution, 100 mL Single - Dose Vial per Carton, Rx Only, Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487, Manufactured by: Pharmaceutics International, Inc., Hunt Valley, MD 21031, NDC 51991-064-98.

by Breckenridge Pharmaceutical, Inc

Reason
Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impurities during stability testing.
Recall initiated
February 24, 2020
Reported by FDA
March 4, 2020
Distribution
Nationwide in the U.S.

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Drug Recall Terminated Historical recordClass I

Phenytoin Oral Suspension USP, 125 mg/5 mL potency, 8 fl oz (237 mL) Rx Only Mfd. by: Taro Pharmaceuticals Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A. Inc. Hawthorne, NY 10532, NDC 51672-4069-1

by Taro Pharmaceuticals U.S.A., Inc.

Reason
Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not resuspend as per the label copy instructions.
Recall initiated
February 7, 2020
Reported by FDA
March 4, 2020
Distribution
Distributed Nationwide in the USA.

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Drug Recall Terminated Historical recordClass III

CVS Health Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distributed By: CVS Pharmacy Inc. One CVS Drive, Woonsocket, RI 02895, NDC 59779-303-01

by Akorn, Inc.

Reason
Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace copper, which are the base of the materials of construction for the tube.
Recall initiated
February 21, 2020
Reported by FDA
March 4, 2020
Distribution
Nationwide within United States and Puerto Rico

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Drug Recall Terminated Historical recordClass III

Well at Walgreens Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distributed by: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015. NDC 0363-9050-00.

by Akorn, Inc.

Reason
Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace copper, which are the base of the materials of construction for the tube.
Recall initiated
February 21, 2020
Reported by FDA
March 4, 2020
Distribution
Nationwide within United States and Puerto Rico

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Drug Recall Terminated Historical recordClass III

Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-622-35

by Akorn, Inc.

Reason
Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace copper, which are the base of the materials of construction for the tube.
Recall initiated
February 21, 2020
Reported by FDA
March 4, 2020
Distribution
Nationwide within United States and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass III

TRAMADOL HYDROCHLORIDE Tablets, USP, 50 mg, Rx Only a)100-count bottles (NDC 60429-588-01) b) 500-count bottle (NDC 60429-588-05) Manufactured by Teva Czech Industries, s.r.o. Opava-Komarov, Czech Republic, Packaged by GSMS Incorporated, Camarillo, CA 93012

by Golden State Medical Supply Inc.

Reason
Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets contain language relative to a 25 mg dosing titration that necessitates the use of a scored 50 mg tablet.
Recall initiated
February 12, 2020
Reported by FDA
March 4, 2020
Distribution
Distributed Nationwide in the USA

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Drug Recall Terminated Historical recordClass III

Glycopyrrolate Injection, USP 4 mg per 20 mL (0.2 mg/mL), 20 mL Multiple Dose Vial, Rx Only, For Intramuscular or Intravenous Use, Not for Use in Newborns, Contains Benzyl Alcohol, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ, 08520, Made in India, NDC 55150-295-20.

by AuroMedics Pharma LLC

Reason
Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in investigative samples (retain samples).
Recall initiated
February 7, 2020
Reported by FDA
February 26, 2020
Distribution
Ohio, Louisiana, Mississippi

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Drug Recall Terminated Historical recordClass III

Tramadol Hydrochloride Tablets USP CIV, 50 mg, packaged in a) 100-count bottles (NDC 0093-0058-01), b) 500-count bottles (NDC 0093-0058-05), RX only, Manufactured in Czech Republic for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19545

by Teva Pharmaceuticals USA

Reason
Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets contain language relative to a 25 mg dosing titration that necessitates the use of a scored 50 mg tablet.
Recall initiated
January 28, 2020
Reported by FDA
February 26, 2020
Distribution
U.S.A. Nationwide

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Drug Recall Terminated Historical recordClass II

Glycopyrrolate Tabs, USP, 1 mg, 30-count unit dose blister card, FOR INSTITUTIONAL USE ONLY, Rx Only, Packaged by Vangard, Glasgow, KY 42141; NDC 0615-8170-39.

by NCS Healthcare of Kentucky Inc

Reason
Failed Impurities/Degradation Specification: High Out of Specification Results for Individual Unknown Impurity.
Recall initiated
January 28, 2020
Reported by FDA
February 26, 2020
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Desmopressin Acetate Tablets, 0.2 mg, 30 tablets (3 x 10 unit dose blister cards), Rx Only, Packaged and distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-604-21; NDC Unit Dose 68084-604-11

by American Health Packaging

Reason
GMP Deviations: Product bottle may be absent of desiccant.
Recall initiated
February 7, 2020
Reported by FDA
February 26, 2020
Distribution
Nationwide USA

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Drug Recall Terminated Historical recordClass II

Desmopressin Acetate Tablets, 0.1 mg, 30 tablets (3 x 10 unit dose blister cards), Rx Only, Packaged and distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-606-21; NDC Unit Dose 68084-606-11

by American Health Packaging

Reason
GMP Deviations: Product bottle may be absent of desiccant.
Recall initiated
February 7, 2020
Reported by FDA
February 26, 2020
Distribution
Nationwide USA

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.