PlainRecalls
FDA Drug Moderate Class II Ongoing

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.

Reported: November 12, 2025 Initiated: October 13, 2025 #D-0151-2026

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

Details

Units Affected
4680 cartons
Distribution
Distributed in three (3) States: MS, OH, CA.
Location
Parsippany, NJ

Frequently Asked Questions

What product was recalled?
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.. Recalled by Teva Pharmaceuticals USA, Inc. Units affected: 4680 cartons.
Why was this product recalled?
Subpotent drug; Clavulanate Potassium component
Which agency issued this recall?
This recall was issued by the FDA Drug on November 12, 2025. Severity: Moderate. Recall number: D-0151-2026.