Class IIOngoing

Amoxicillin and Clavulanate Potassium for Oral Suspension USP recall

FDA recall D-0151-2026 · initiated Oct 13, 2025

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

Subpotent drug; Clavulanate Potassium component

Details

Product: 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.
Recalling company: Teva Pharmaceuticals USA, Inc.
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Distributed in three (3) States: MS, OH, CA.
Initiated: Oct 13, 2025
FDA report date: Nov 12, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0151-2026 ↗

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