Amoxicillin and Clavulanate Potassium for Oral Suspension USP recall
FDA recall D-0151-2026 · initiated Oct 13, 2025
Teva Pharmaceuticals USA, Inc recalled Amoxicillin and Clavulanate Potassium for Oral Suspension USP in Oct 2025 — an FDA Class II recall (D-0151-2026) because Subpotent drug; Clavulanate Potassium component.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Subpotent drug; Clavulanate Potassium component
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 4680 cartons
Details
- 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.
- Recalling company
- Teva Pharmaceuticals USA, Inc.
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Distributed in three (3) States: MS, OH, CA.
- Initiated
- Oct 13, 2025
- FDA report date
- Nov 12, 2025
Frequently asked
- Was Amoxicillin and Clavulanate Potassium for Oral Suspension USP recalled?
- Teva Pharmaceuticals USA, Inc recalled Amoxicillin and Clavulanate Potassium for Oral Suspension USP in Oct 2025 — an FDA Class II recall (D-0151-2026) because Subpotent drug; Clavulanate Potassium component. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Amoxicillin and Clavulanate Potassium for Oral Suspension USP recalled?
- Per the FDA enforcement record, the reason for recall D-0151-2026 was: Subpotent drug; Clavulanate Potassium component
- Is a recalled Amoxicillin and Clavulanate Potassium for Oral Suspension USP dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Amoxicillin and Clavulanate Potassium for Oral Suspension USP are affected?
- Distributed: Distributed in three (3) States: MS, OH, CA.. The recall covers these lots — Lot # 100062316, Exp Date: 01/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0151-2026.