FDAHealthNovember 7, 2025
Teva Pharmaceuticals USA, Inc — 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, D
⚠️ Defective Container - A defect in the side-seal which allows leakage of product.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- November 7, 2025
U.S. Nationwide
What's affected?
- Product
- 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.
- Brand
- TESTOSTERONE
- Lot code
- 100068692
Additional details
Lot #100068692, Exp.: 04/30/2027
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 15,944 cartons.
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