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.
Reported: December 10, 2025 Initiated: November 7, 2025 #D-0198-2026
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.
Details
- Recalling Firm
- Teva Pharmaceuticals USA, Inc
- Units Affected
- 15,944 cartons
- Distribution
- U.S. Nationwide
- Location
- Parsippany, NJ
Frequently Asked Questions
What product 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.. Recalled by Teva Pharmaceuticals USA, Inc. Units affected: 15,944 cartons.
Why was this product recalled? ▼
Defective Container - A defect in the side-seal which allows leakage of product.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 10, 2025. Severity: Low. Recall number: D-0198-2026.
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