Actavis Testosterone Gel Recalled for Defect

The US Food and Drug Administration (FDA) has announced a Class III recall for Testosterone Gel 1% (2.5 grams per unit dose), packaged in 30-unit dose packets and classified as a Schedule III controlled substance. The recall affects 15 944 cartons from Lot #100068692, with an expiration date of April 30, 2027. The product was manufactured by Actavis Laboratories, Inc., in Salt Lake City, Utah, and distributed by Teva Pharmaceuticals USA, Inc., headquartered in Parsippany, New Jersey. The issue prompting the recall was a defective side-seal in the packet, which can result in leakage of the gel.

The recall was voluntarily initiated by the firm on November 7, 2025, and was officially classified as Class III by the FDA on December 1, 2025. A Class III recall indicates that use of the product is unlikely to cause adverse health consequences, but the product’s quality or performance may still be compromised. In this case, the concern is that seal leakage could result in underdosing or unintentional exposure, particularly with testosterone, which carries the risk of transference to others through skin contact.

Testosterone Gel 1% is indicated for replacement therapy in adult males with conditions associated with a deficiency or absence of endogenous testosterone, such as hypogonadism or hypopituitarism. As a topical product, proper packaging integrity is essential to ensure accurate dosing and minimize unintentional exposure. Pharmacists should verify Lot #100068692, remove any affected cartons from inventory, and counsel patients on the importance of proper application, storage, and handling. Replacement or substitution with unaffected lots should be coordinated with prescribers to maintain consistent testosterone levels and therapy outcomes.

Reference

FDA. Enforcement Report. December 3, 2025. Accessed December 4, 2025. https://www.accessdata.fda.gov/scripts/ires/index.cfm