Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA drug recalls in 2018

Every FDA drug recall initiated in 2018, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.

1,681 recalls, newest first.

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
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

Recalls by year