FDA recall D-0151-2026

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.

Reason for recall

Subpotent drug; Clavulanate Potassium component

Distribution

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

Key facts

Status

Ongoing

Initiation date

2025-10-13

Report date

2025-11-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0151-2026