FDA Recall D-0198-2026

Teva Pharmaceuticals USA, Inc · Parsippany, NJ

Class III Ongoing 188 days on record

Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.

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.

Lot / code: Lot #100068692, Exp.: 04/30/2027

Quantity: 15,944 cartons

Reason for recall

Defective Container - A defect in the side-seal which allows leakage of product.

Recall record

Recall number: D-0198-2026
Classification: Class III
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: U.S. Nationwide
Recall initiated: 2025-11-07
Classified by FDA Center: 2025-12-01
FDA published: 2025-12-10
Recalling firm: Teva Pharmaceuticals USA, Inc
Firm location: Parsippany, NJ

Drug identification

Brand name(s): TESTOSTERONE
Generic name(s): TESTOSTERONE
Manufacturer(s): Actavis Pharma, Inc.
NDC(s): 0591-2921, 0591-3216, 0591-3217
Route(s): TOPICAL

Operational response

Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.

For the official FDA enforcement record, see FDA's Recall Search.

‹ All recalls