Class III
Ongoing
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.
This recall is currently active, issued December 10, 2025. It was issued by Teva Pharmaceuticals Usa, Inc.
- Company
- Teva Pharmaceuticals Usa, Inc
- Recall Initiated
- November 7, 2025
- Posted
- December 10, 2025
- Recall Number
- D-0198-2026
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 15,944 cartons
- Firm Location
- Parsippany, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Defective Container - A defect in the side-seal which allows leakage of product.
Distribution
U.S. Nationwide
Lot / Code Info
Lot #100068692, Exp.: 04/30/2027
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