Amoxicillin and Clavulanate Potassium Tablets USP recall
FDA recall D-0561-2024 · initiated Jun 4, 2024
Teva Pharmaceuticals USA, Inc recalled Amoxicillin and Clavulanate Potassium Tablets USP in Jun 2024 — an FDA Class II recall (D-0561-2024) because Subpotent Drug.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Subpotent Drug
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: 34,448 bottles
Details
- Product
- Amoxicillin and Clavulanate Potassium Tablets USP, Chewable 400mg/57mg, 20-count bottles, Rx only, Manufactured in Canada By: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0093-2272-34
- Recalling company
- Teva Pharmaceuticals USA, Inc.
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States
- Initiated
- Jun 4, 2024
- FDA report date
- Jun 26, 2024
Frequently asked
- Was Amoxicillin and Clavulanate Potassium Tablets USP recalled?
- Teva Pharmaceuticals USA, Inc recalled Amoxicillin and Clavulanate Potassium Tablets USP in Jun 2024 — an FDA Class II recall (D-0561-2024) because Subpotent Drug. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Amoxicillin and Clavulanate Potassium Tablets USP recalled?
- Per the FDA enforcement record, the reason for recall D-0561-2024 was: Subpotent Drug
- Is a recalled Amoxicillin and Clavulanate Potassium Tablets 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 Tablets USP are affected?
- Distributed: Nationwide within the United States. The recall covers these lots — Lot #: 100047634 Exp. Date 4/2025; 35449379A, Exp. Date 7/2024. 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-0561-2024.