Independent register of U.S. FDA drug recalls · updated Oct 13, 2026
RxRecalls Get alerts

FDA Drug Recalls

11,818 recalls · Class II, newest first

Class II · Moderate risk

Valacyclovir Tablets USP 1 gram

Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018).

Terminated Temperature excursion Hetero Labs Limited Unit V NDC 31722-705-30 D-0602-2018
Class II · Moderate risk

Valganciclovir Tablets

Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018).

Terminated Temperature excursion Hetero Labs Limited Unit V NDC 31722-832-60 D-0601-2018
Class II · Moderate risk

Acyclovir Tablets

Presence of Foreign Tablet/Capsule; cartons labeled to contain Acyclovir tablets may contain Torsemide tablets in some of the blister cavities.

Terminated Particulate / foreign matter Apace KY LLC NDC 50268-061-11 D-0544-2018
Class II · Moderate risk

Fluticasone propionate 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 58597-8276-3 D-0539-2018
Class II · Moderate risk

Cyanocobalamin 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 58597-8044-1 D-0538-2018
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

Recalls by year