Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

Defective Container - A defect in the side-seal which allows leakage of product.

What was recalled

Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis Laboratories, Inc, Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3216-30. Packet label: Testosterone Gel 1%, contains 2.5 grams, For topical use only, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054,NDC: 0591-3216-17.

Recalling firm: Teva Pharmaceuticals USA, Inc
NDC code: 0591-3216-30
Origin: NJ, United States
Initiated by: Voluntary: Firm initiated
FDA recall number: D-0198-2026

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.