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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 9,821–9,840 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

Ascorbic Acid USP, for prescription compounding, packaged in a) 100g (NDC 58597-8120-6); b) 500g (NDC 58597-8120-7); c) 1000g (NDC 58597-8120-8); d) 5000g (NDC 58597-8120-9); e) 25000g (NDC 58597-8120-3), RX only, packed by American Pharmaceutical Ingredients, LLC 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

Verapamil HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8039-6); b) 500g (NDC 58597-8039-7); c) 1000g (NDC 58597-8039-8), RX only, packed by American Pharmaceutical Ingredients, LLC 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

Vardenafil HCl USP (trihydrate) for prescription compounding, packaged in a) 5g (NDC 58597-8575-2); b) 100g (NDC 58597-8575-6);c) 500g (NDC 58597-8575-7); d) 1000g (NDC 58597-8575-8), RX only, packed by American Pharmaceutical Ingredients, LLC 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

Vancomycin HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8091-4); b) 100g (NDC 58597-8091-6); c) 500g (NDC 58597-8091-7), RX only, packed by American Pharmaceutical Ingredients, LLC 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

Ursodiol USP for prescription compounding, packaged in a) 100g (NDC 58597-8038-6); b) 500g (NDC 58597-8038-7), RX only, packed by American Pharmaceutical Ingredients, LLC 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

Tretinoin USP for prescription compounding, packaged in a) 5g (NDC 58597-8033-2); 1b) 10g (NDC 58597-8033-3); c) 25g (NDC 58597-8033-4), RX only, packed by American Pharmaceutical Ingredients, LLC 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

Tramadol HCl USP (CIV) for prescription compounding, packaged in a) 25g (NDC 58597-8032-4); b) 100g (NDC 58597-8032-6); c) 500g (NDC 58597-8032-7); d)1000g (NDC 58597-8032-8), RX only, packed by American Pharmaceutical Ingredients, LLC 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

Testosterone USP (Micronized) (Yam) for prescription compounding, packaged in a) 25g (NDC 58597-8546-4); b) 100g (NDC 58597-8546-6); c) 500g (NDC 58597-8546-7); d) 1000g (NDC 58597-8546-8), RX only, packed by American Pharmaceutical Ingredients, LLC 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

Testosterone Enanthate USP for prescription compounding, packaged in a) 25g (NDC 58597-0079-4); b) 100g (NDC 58597-0079-6); c) 500g (NDC 58597-0079-7); d) 1000g (NDC 58597-0079-8), RX only, packed by American Pharmaceutical Ingredients, LLC 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

Testosterone Cypionate USP (Micronized) for prescription compounding, packaged in a)100g (NDC 58597-0078-6); b) 500g (NDC 58597-0078-7); c) 1000g (NDC 58597-0078-8), RX only, packed by American Pharmaceutical Ingredients, LLC 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

Testosterone (Soy) (Micronized) USP for prescription compounding, packaged in a) 25g (NDC 58597-0077-4); b) 100g (NDC 58597-0077-6), c) 500g (NDC 58597-0077-7); d)1000g (NDC 58597-0077-8), RX only, packed by American Pharmaceutical Ingredients, LLC 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

Tadalafil USP (Monohydrate) for prescription compounding, packaged in a) 5g (NDC 58597-8538-2); b) 25g (NDC 58597-8538-4); c)100g (NDC 58597-8538-6); d) 500g (NDC 58597-8538-7); d) 1000g (NDC 58597-8538-8), RX only, packed by American Pharmaceutical Ingredients, LLC 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

Tacrolimus USP (Monohydrate) for prescription compounding, packaged in a) 1g (NDC 58597-8029-4); b) 5g (NDC 58597-8029-5), RX only, packed by American Pharmaceutical Ingredients, LLC 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

Sumatriptan USP for prescription compounding, packaged in 10g (NDC 58597-8089-3); b) 25g (NDC 58597-8089-4); c)100g (NDC 58597-8089-6), RX only, packed by American Pharmaceutical Ingredients, LLC 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

Sumatriptan Succinate USP for prescription compounding, 25g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327, NDC 58597-8633-4.

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

Stanozolol USP for prescription compounding, packaged in a) 25g (NDC 58597-8525-3);b)100g (NDC 58597-8525-6); c) 500g (NDC 58597-8525-7); d)1000g (NDC 58597-8525-8), RX only, packed by American Pharmaceutical Ingredients, LLC 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

Sildenafil Citrate USP for prescription compounding, packaged in a) 5g (NDC 58597-8088-2);b) 25g (NDC 58597-8088-4); c) 50g (NDC 58597-8088-5); d) 100g (NDC 58597-8088-6); e) 500g (NDC 58597-8088-7); f)1000g (NDC 58597-8088-8), RX only, packed by American Pharmaceutical Ingredients, LLC 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

Progesterone USP (Micronized) (Yam) for prescription compounding, packaged in a) 1g (NDC 58597-8471-1); b) 10g (NDC 58597-8471-3); c) 25g (NDC 58597-8471-4); d) 100g (NDC 58597-8471-6); e) 500g (NDC 58597-8471-7); f) 1000g (NDC 58597-8471-8); g) 5000g (NDC 58597-8471-9), RX only, packed by American Pharmaceutical Ingredients, LLC 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

Prilocaine HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8028-6); b) 500g (NDC 58597-8028-7); c) 1000g (NDC 58597-8028-8), RX only, packed by American Pharmaceutical Ingredients, LLC 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

Phentolamine Mesylate USP for prescription compounding, packaged in a) 1g (NDC 58597-8077-3); b) 5g (NDC 58597-8077-4); c) 500g (NDC 58597-8077-7), RX only, packed by American Pharmaceutical Ingredients, LLC 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 →

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.