Teva Pharmaceuticals USA Inc: Drug Recall

Recall #D-1156-2022 · 06/14/2022

Class II: Risk

Recall Details

Recall Number: D-1156-2022
Classification: Class II
Product Type: Drug
Recalling Firm: Teva Pharmaceuticals USA Inc
Status: Terminated
Date Initiated: 06/14/2022
Location: Parsippany, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4941 bottles

Reason for Recall

Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution.

Product Description

Tretinoin Capsules, 10 mg, Rx Only, 100 capsules per bottle, Teva Pharmaceuticals USA Inc., North Wales, PA, 19454, NDC 0555-0808-02.

Distribution Pattern

Nationwide in the U.S.

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.