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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 9,881–9,900 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

Anastrozole USP for prescription compounding, packaged in a) 1g ( NDC 58597-8080-1), b) 5g (NDC 58597-8080-2), c) 25g (NDC 58597-8080-4), RX only, packed by American Pharmaceutical Ingredients, 6650 Highland Road, Waterford, MI 48327.

by American Pharmaceutical Ingredients LLC

Reason
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Recall initiated
February 9, 2018
Reported by FDA
February 28, 2018
Distribution
Nationwide within USA.

View recall →

Drug Recall Terminated Historical recordClass II

Amitriptyline HCl USP for prescription compounding , packaged in a) 25 g (NDC 58597-8003-4); b) 100 g (NDC 58597-8003-6); c) 500 g (NDC 58597-8003-7), d) 1000 g (NDC 58597-8003-8), RX only, packed by American Pharmaceutical Ingredients, 6650 Highland Road, Waterford, MI 48327.

by American Pharmaceutical Ingredients LLC

Reason
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Recall initiated
February 9, 2018
Reported by FDA
February 28, 2018
Distribution
Nationwide within USA.

View recall →

Drug Recall Terminated Historical recordClass III

Calcium Acetate Capsules, 667 mg, 200 Capsules per bottle, Rx Only. Manufactured by Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-026-02

by Nostrum Laboratories Inc

Reason
Presence of Foreign Tablets/Capsules
Recall initiated
February 13, 2018
Reported by FDA
February 28, 2018
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Nicardipine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.

by PharMEDium Services, LLC

Reason
Lack of sterility assurance.
Recall initiated
December 27, 2017
Reported by FDA
February 28, 2018
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Dexamethasone Sodium Phosphate added to 5% Dextrose in all strengths, all doses, and all packaging.

by PharMEDium Services, LLC

Reason
Lack of sterility assurance.
Recall initiated
December 27, 2017
Reported by FDA
February 28, 2018
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Rocuronium Bromide in all strengths, all doses, and all packaging.

by PharMEDium Services, LLC

Reason
Lack of sterility assurance.
Recall initiated
December 27, 2017
Reported by FDA
February 28, 2018
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Methadone HCl Injection in all strengths, all doses, and all packaging.

by PharMEDium Services, LLC

Reason
Lack of sterility assurance.
Recall initiated
December 27, 2017
Reported by FDA
February 28, 2018
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Meperidine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.

by PharMEDium Services, LLC

Reason
Lack of sterility assurance.
Recall initiated
December 27, 2017
Reported by FDA
February 28, 2018
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Esmolol HCl in all strengths, all doses, and all packaging.

by PharMEDium Services, LLC

Reason
Lack of sterility assurance.
Recall initiated
December 27, 2017
Reported by FDA
February 28, 2018
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Dexamethasone Sodium Phosphate added to 0.9% Sodium Chloride in all strengths, all doses, and all packaging.

by PharMEDium Services, LLC

Reason
Lack of sterility assurance.
Recall initiated
December 27, 2017
Reported by FDA
February 28, 2018
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Vecuronium Bromide in Sterile Water for Injection in all strengths, all doses, and all packaging.

by PharMEDium Services, LLC

Reason
Lack of sterility assurance.
Recall initiated
December 27, 2017
Reported by FDA
February 28, 2018
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Neostigmine Methylsulfate Injection in all strengths, all doses, and all packaging.

by PharMEDium Services, LLC

Reason
Lack of sterility assurance.
Recall initiated
December 27, 2017
Reported by FDA
February 28, 2018
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Labetalol HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.

by PharMEDium Services, LLC

Reason
Lack of sterility assurance.
Recall initiated
December 27, 2017
Reported by FDA
February 28, 2018
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Nicardipine HCl in all strengths, all doses, and all packaging.

by PharMEDium Services, LLC

Reason
Lack of sterility assurance.
Recall initiated
December 27, 2017
Reported by FDA
February 28, 2018
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Ropivacaine HCl Injection in all strengths, all doses, and all packaging.

by PharMEDium Services, LLC

Reason
Lack of sterility assurance.
Recall initiated
December 27, 2017
Reported by FDA
February 28, 2018
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

HYDROmorphone HCl in 5% Dextrose in all strengths, all doses, and all packaging.

by PharMEDium Services, LLC

Reason
Lack of sterility assurance.
Recall initiated
December 27, 2017
Reported by FDA
February 28, 2018
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Atropine Sulfate Injection in all strengths, all doses, and all packaging.

by PharMEDium Services, LLC

Reason
Lack of sterility assurance.
Recall initiated
December 27, 2017
Reported by FDA
February 28, 2018
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Lidocaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.

by PharMEDium Services, LLC

Reason
Lack of sterility assurance.
Recall initiated
December 27, 2017
Reported by FDA
February 28, 2018
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Glycopyrrolate in all strengths, all doses, and all packaging.

by PharMEDium Services, LLC

Reason
Lack of sterility assurance.
Recall initiated
December 27, 2017
Reported by FDA
February 28, 2018
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Ropivacaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.

by PharMEDium Services, LLC

Reason
Lack of sterility assurance.
Recall initiated
December 27, 2017
Reported by FDA
February 28, 2018
Distribution
U.S.A. 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.