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

Methylcobalamin

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 58597-8142-1 D-0537-2018
Class II · Moderate risk

Biotin 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 58597-8142-1 D-0536-2018
Class II · Moderate risk

Ascorbic Acid 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 58597-8120-6 D-0535-2018
Class II · Moderate risk

Verapamil 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 58597-8039-6 D-0534-2018
Class II · Moderate risk

Vardenafil 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 58597-8575-2 D-0533-2018
Class II · Moderate risk

Ursodiol 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 58597-8038-6 D-0531-2018
Class II · Moderate risk

Tretinoin 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 58597-8033-2 D-0530-2018
Class II · Moderate risk

Tramadol 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 58597-8032-4 D-0529-2018
Class II · Moderate risk

Testosterone 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 58597-8546-4 D-0528-2018
Class II · Moderate risk

Testosterone Cypionate 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 58597-0078-6 D-0526-2018
Class II · Moderate risk

Testosterone

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 58597-0077-4 D-0525-2018
Class II · Moderate risk

Tadalafil 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 58597-8538-2 D-0524-2018
Class II · Moderate risk

Tacrolimus 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 58597-8029-4 D-0523-2018
Class II · Moderate risk

Sumatriptan 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 58597-8089-3 D-0522-2018
Class II · Moderate risk

Stanozolol 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 58597-8525-3 D-0520-2018
Class II · Moderate risk

Progesterone 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 58597-8471-1 D-0518-2018
Class II · Moderate risk

Oxandrolone 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 58597-0082-4 D-0514-2018
Class II · Moderate risk

Nifedipine 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 58597-8025-2 D-0513-2018

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