Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Is Testosterone recalled?

Yes — there is an active recall. 69 ongoing FDA recalls mention Testosterone (406 total). Check the affected lots below.

Recalls are matched by product description. A recall usually affects specific lots, not every package of Testosterone. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.

Testosterone recalls on record

none so far in 2026; 406 on record, newest first
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

Testosterone Cypionate 200 mg/mL

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Terminated Sterility / contamination Isomeric Pharmacy Solution, LLC D-0686-2017
Class II · Moderate risk

Testosterone Micronized

cGMP Deviations; lack of quality assurance.

Terminated cGMP deviation Qinhuangdao Zizhu Pharmaceutical, Co. NDC 44132-006-06 D-0658-2017