Recall
FDAHealthOctober 13, 2025

Teva Pharmaceuticals USA, Inc — 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 Limi

⚠️ Subpotent drug; Clavulanate Potassium component

Is this relevant to me?

Geography
MS, OH, CA
Source agency
FDA
Category
Health
Published
October 13, 2025

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

What's affected?

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.
Lot code
100062316

Additional details

Lot # 100062316, Exp Date: 01/2026

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 4680 cartons.

View original FDA notice →

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