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CLASS II · ModerateFDA

Teva Pharmaceuticals USA, Inc recalls Amoxicillin and Clavulanate Potassium for Oral Suspension USP

📅 Oct 13, 2025 · 📍 CA, MS, OH
Recalling company
Teva Pharmaceuticals USA, Inc
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
Subpotent drug; Clavulanate Potassium component
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Oct 13, 2025
Reported
Nov 12, 2025
Distribution
Distributed in three (3) States: MS, OH, CA.
Status
Ongoing
Quantity
4680 cartons
Lot / codes
Lot # 100062316, Exp Date: 01/2026
Company location
Parsippany, NJ
Recall type
Voluntary: Firm initiated
Recall number
D-0151-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number D-0151-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.