Teva Pharmaceuticals USA, Inc: Drug Recall

Recall #D-0198-2026 · 11/07/2025

Class III: Low Risk

Recall Details

Recall Number: D-0198-2026
Classification: Class III
Product Type: Drug
Recalling Firm: Teva Pharmaceuticals USA, Inc
Status: Ongoing
Date Initiated: 11/07/2025
Location: Parsippany, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 15,944 cartons

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.

Distribution Pattern

U.S. Nationwide

Other Recalls by Teva Pharmaceuticals USA, Inc

Class II: Risk 10/13/2025

Subpotent drug; Clavulanate Potassium component
Class II: Risk 10/07/2025

CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
Class II: Risk 10/07/2025

CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
Class II: Risk 10/07/2025

CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
Class II: Risk 05/23/2025

Presence of foreign tablets/capsules.

View all recalls by Teva Pharmaceuticals USA, Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.