Teva Pharmaceuticals USA, Inc recalls Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actav…

Recall date

November 7, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0198-2026

FDA classification

Class III

Brand / firm

Teva Pharmaceuticals USA, Inc

Sold / distributed

U.S. Nationwide

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

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.