Teva Pharmaceuticals USA, Inc: Drug Recall

Recall #D-0127-2024 · 11/10/2023

Class III: Low Risk

Recall Details

Recall Number: D-0127-2024
Classification: Class III
Product Type: Drug
Recalling Firm: Teva Pharmaceuticals USA, Inc
Status: Terminated
Date Initiated: 11/10/2023
Location: Parsippany, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated

Reason for Recall

OOS for viscosity

Product Description

Testosterone Gel, 1.62% CIII (Alcohol 80% v/v), packaged in 30 unit-dose packets per carton, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0591-2926-30

Distribution Pattern

USA nationwide

Other Recalls by Teva Pharmaceuticals USA, Inc

Class III: Low Risk 11/07/2025

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

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.