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, I
Recall Summary Actavis Laboratories' Testosterone Gel 1% in 30-packet cartons (NDC 0591-3216-30) is being recalled nationwide because the packets have a defective side-seal that can cause the product to leak. This recall affects all U.S. states and territories. Patients who have this medication should check if their carton matches the recalled product information.
- Recalling firm
- Teva Pharmaceuticals USA, Inc
- 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.
- Reason
- Defective Container - A defect in the side-seal which allows leakage of product.
- Classification
- Class I
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2025-11-07
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- U.S. Nationwide
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/1cc04557-df39-4cb2-a511-662e0b747584