Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, ...
FDA Recall #D-0198-2026 — Class III — November 7, 2025
Product Description
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.
Reason for Recall
Defective Container - A defect in the side-seal which allows leakage of product.
Recalling Firm
Teva Pharmaceuticals USA, Inc — Parsippany, NJ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
15,944 cartons
Distribution
U.S. Nationwide
Code Information
Lot #100068692, Exp.: 04/30/2027
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated