FDA Recall D-0151-2026

Teva Pharmaceuticals USA, Inc · Parsippany, NJ

Class II Ongoing 213 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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: Lot # 100062316, Exp Date: 01/2026

Quantity: 4680 cartons

Reason for recall

Subpotent drug; Clavulanate Potassium component

Recall record

Recall number: D-0151-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Distributed in three (3) States: MS, OH, CA.
Recall initiated: 2025-10-13
Classified by FDA Center: 2025-11-03
FDA published: 2025-11-12
Recalling firm: Teva Pharmaceuticals USA, Inc
Firm location: Parsippany, NJ

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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