Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
RxRecalls Get alerts

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

Testo-100 Ciii

Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.

Ongoing Sterility / contamination Advanced Pharmaceutical Technology, Inc. NDC 57377-100-01 D-0258-2026
Class II · Moderate risk

Testo-200

Marketed Without an Approved NDA/ANDA

Ongoing Unapproved drug Advanced Pharmaceutical Technology, Inc. NDC 57377-200-01 D-0531-2025
Class II · Moderate risk

Testosterone Cypionate Injection

cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.

Ongoing cGMP deviation Eugia US LLC NDC 55150-277-01 D-0363-2025
Class II · Moderate risk

Testosterone Cypionate Injection

cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.

Terminated cGMP deviation Azurity Pharmaceuticals, Inc. NDC 52536-625-10 D-0489-2023
Class II · Moderate risk

Testosterone 3%

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Terminated Sterility / contamination Pharmacy Innovations D-0238-2023
Class II · Moderate risk

Testosterone Gel 1%

Superpotent Drug: Out of specification assay result was obtained during stability testing.

Terminated Wrong potency / content Teva Pharmaceuticals USA Inc NDC 0591-3216-17 D-1289-2022