Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA Drug Recalls

982 recalls · Class II, newest first

Class II · Moderate risk

Naltrexone HCl USP

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Terminated Stability / shelf life American Pharmaceutical Ingredients LLC NDC 58597-8407-1 D-0511-2018
Class II · Moderate risk

Medroxyprogesterone Acetate USP

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Terminated Stability / shelf life American Pharmaceutical Ingredients LLC NDC 58597-8055-8 D-0510-2018
Class II · Moderate risk

Lidocaine USP for prescription compounding

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Terminated Stability / shelf life American Pharmaceutical Ingredients LLC NDC 58597-8019-4 D-0507-2018
Class II · Moderate risk

Lidocaine HCl USP for prescription compounding

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Terminated Stability / shelf life American Pharmaceutical Ingredients LLC NDC 58597-8020-6 D-0506-2018
Class II · Moderate risk

Levetiracetam USP for prescription compounding

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Terminated Stability / shelf life American Pharmaceutical Ingredients LLC NDC 58597-8353-7 D-0502-2018
Class II · Moderate risk

Ketoprofen USP

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Terminated Stability / shelf life American Pharmaceutical Ingredients LLC NDC 58597-8336-4 D-0500-2018
Class II · Moderate risk

Ketoconazole USP for prescription compounding

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Terminated Stability / shelf life American Pharmaceutical Ingredients LLC NDC 58597-8053-4 D-0499-2018
Class II · Moderate risk

Ketamine HCl USP for prescription compounding

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Terminated Stability / shelf life American Pharmaceutical Ingredients LLC NDC 58597-8333-4 D-0498-2018
Class II · Moderate risk

Itraconazole USP

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Terminated Stability / shelf life American Pharmaceutical Ingredients LLC NDC 58597-8133-3 D-0497-2018
Class II · Moderate risk

Imiquimod USP for prescription compounding

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Terminated Stability / shelf life American Pharmaceutical Ingredients LLC NDC 58597-8317-1 D-0496-2018
Class II · Moderate risk

Gabapentin USP for prescription compounding

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Terminated Stability / shelf life American Pharmaceutical Ingredients LLC NDC 58597-8014-4 D-0494-2018
Class II · Moderate risk

Flurbiprofen USP for prescription compounding

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Terminated Stability / shelf life American Pharmaceutical Ingredients LLC NDC 58597-8075-4 D-0493-2018
Class II · Moderate risk

Fluconazole USP for prescription compounding

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Terminated Stability / shelf life American Pharmaceutical Ingredients LLC NDC 58597-8268-4 D-0492-2018
Class II · Moderate risk

Estrone USP for prescription compounding

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Terminated Stability / shelf life American Pharmaceutical Ingredients LLC NDC 58597-8049-3 D-0491-2018
Class II · Moderate risk

Estriol USP

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Terminated Stability / shelf life American Pharmaceutical Ingredients LLC NDC 58597-8048-2 D-0490-2018
Class II · Moderate risk

Estradiol Hemihydrate USP

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Terminated Stability / shelf life American Pharmaceutical Ingredients LLC NDC 58597-8001-3 D-0489-2018
Class II · Moderate risk

Estradiol USP

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Terminated Stability / shelf life American Pharmaceutical Ingredients LLC NDC 58597-8047-1 D-0488-2018

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