Teva Pharmaceuticals USA, Inc: Drug Recall

Recall #D-0151-2026 · 10/13/2025

Class II: Risk

Recall Details

Recall Number: D-0151-2026
Classification: Class II
Product Type: Drug
Recalling Firm: Teva Pharmaceuticals USA, Inc
Status: Ongoing
Date Initiated: 10/13/2025
Location: Parsippany, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4680 cartons

Reason for Recall

Subpotent drug; Clavulanate Potassium component

Product Description

Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg per 5mL, 100 mL (when reconstituted), Rx only, manufactured in Canada by: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054 NDC 0093-2277-7.

Distribution Pattern

Distributed in three (3) States: MS, OH, CA.

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 10/07/2025

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.