Recalls / Class II
Class IID-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.
- Affected lot / code info
- Lot # 100062316, Exp Date: 01/2026
Why it was recalled
Subpotent drug; Clavulanate Potassium component
Recalling firm
- Firm
- Teva Pharmaceuticals USA, Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy Bldg A, N/A, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 4680 cartons
- Distribution pattern
- Distributed in three (3) States: MS, OH, CA.
Timeline
- Recall initiated
- 2025-10-13
- FDA classified
- 2025-11-03
- Posted by FDA
- 2025-11-12
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0151-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.