D-0151-2026 Class II Ongoing
FDA drug recall D-0151-2026 was initiated by Teva Pharmaceuticals USA, Inc on Oct 13, 2025 and is designated Class II. Reason for recall: Subpotent drug; Clavulanate Potassium component The recall status is ongoing. Affected quantity: 4680 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- Nov 12, 2025
- Initiation Date
- Oct 13, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4680 cartons
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.
Reason for Recall
Subpotent drug; Clavulanate Potassium component
Distribution Pattern
Distributed in three (3) States: MS, OH, CA.
Code Information
Lot # 100062316, Exp Date: 01/2026
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0151-2026
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026