CLASS II Drug recall · Reported 14 Feb 2024 · FDA Enforcement Report
Febuxostat Tablets, 40 mg (3 recalled by Amerisource Health Services
Amerisource Health Services is recalling Febuxostat Tablets, 40 mg (3 x per, distributed nationwide in the US. The recall was initiated on 25 Jan 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0314-2024
- FDA event ID
- 93918
- Recalling firm
- Amerisource Health Services, Columbus, OH
- Brand
- Febuxostat
- Manufacturer
- American Health Packaging
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Jan 2024
- FDA classified
- 6 Feb 2024
- Reported
- 14 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 25 Jan 2024 | Recall initiated by company | |
| 6 Feb 2024 | Classified by FDA | +12 days |
| 14 Feb 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations
Product as listed by the FDA
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
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
CGMP Deviations
Which lots are affected?
Lot # 1015033, exp. 06/30/2025; 1016409, exp. 08/31/2025
Where was it sold?
USA Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Amerisource Health Services
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|---|---|---|---|---|---|
| Drug | CLASS III | Primidone Tablets, USP, 250 mg ( unit dose blister) recalledPrimidone | Amerisource Health Services | Packaging Defects | Nationwide |
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| Drug | CLASS II | Oxycodone Hydrochloride Tablets, USP (CII), 5 mg recalledOxycodone Hydrochloride | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Prazosin Hydrochloride, Capsules, USP, 1 mg recalledPrazosin Hydrochloride | Amerisource Health Services | Nitrosamine Impurity | Nationwide |
Other Febuxostat recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Febuxostat Tablets 40mg recalled by Sun Pharmaceutical IndustriesFebuxostat | SUN Pharmaceutical Industries | Sterility | Nationwide |
| Drug | CLASS II | Febuxostat Tablets 80mg recalled by Sun Pharmaceutical IndustriesFebuxostat | SUN Pharmaceutical Industries | Sterility | Nationwide |
| Drug | CLASS II | Febuxostat Tablets 40mg recalled by Sun Pharmaceutical IndustriesFebuxostat | SUN Pharmaceutical Industries | Sterility | Nationwide |
| Drug | CLASS II | Febuxostat Tablets 80 mg recalled by Sun Pharmaceutical IndustriesFebuxostat | SUN Pharmaceutical Industries | Sterility | Nationwide |
| Drug | CLASS II | Febuxostat Tablet, 40 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |