Febuxostat Tablets recall
FDA recall D-0314-2024 · initiated Jan 25, 2024
Amerisource Health Services LLC recalled Febuxostat Tablets in Jan 2024 — an FDA Class II recall (D-0314-2024) because CGMP Deviations.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
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: 1,932 cartons
Details
- Product
- Febuxostat Tablets, 40 mg, 30 Tablets (3 x 10) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-538-21, NDC Unit dose 60687-538-11
- Recalling company
- Amerisource Health Services LLC
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- USA Nationwide
- Initiated
- Jan 25, 2024
- FDA report date
- Feb 14, 2024
Frequently asked
- Was Febuxostat Tablets recalled?
- Amerisource Health Services LLC recalled Febuxostat Tablets in Jan 2024 — an FDA Class II recall (D-0314-2024) because CGMP Deviations. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Febuxostat Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0314-2024 was: CGMP Deviations
- Is a recalled Febuxostat Tablets 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 Febuxostat Tablets are affected?
- Distributed: USA Nationwide. The recall covers these lots — Lot # 1015033, exp. 06/30/2025; 1016409, exp. 08/31/2025. 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-0314-2024.