Recalling firm
Teva Pharmaceuticals USA, Inc
Product type
Drug
Status
Ongoing
Report date
2025-12-10
Distribution
U.S. Nationwide
Firm state
NJ
Product quantity
15,944 cartons
Initiated by
Voluntary: Firm initiated
Reason for recall
Defective Container - A defect in the side-seal which allows leakage of product.
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.
Code / lot info
Lot #100068692, Exp.: 04/30/2027
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.