Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg per 5mL, 100 mL (wh...
FDA Recall #D-0151-2026 — Class II — October 13, 2025
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
Recalling Firm
Teva Pharmaceuticals USA, Inc — Parsippany, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
4680 cartons
Distribution
Distributed in three (3) States: MS, OH, CA.
Code Information
Lot # 100062316, Exp Date: 01/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated