FDA Drugs recall ·
Amoxicillin and Clavulanate Potassium for Oral Suspension USP… recall
- Recall number
- D-0151-2026
- Date
- (initiated October 13, 2025)
- Company / brand
- Teva Pharmaceuticals USA, Inc
400 Interpace Pkwy Bldg A, Parsippany, NJ, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 4680 cartons
- Hazard tags
- Potency
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Subpotent drug; Clavulanate Potassium component
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot # 100062316, Exp Date: 01/2026
Distribution
Distributed in three (3) States: MS, OH, CA.
States: California Mississippi Ohio
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0151-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.