Drug FDA Class II Terminated cGMP deviation
Voriconazole Tablets, 50 mg, packaged in cartons of 3 blister cards with 10 individual blistered doses (30 Unit Dose per carton), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC 60687-294-21, Unit Dose NDC 60687-294-11.
Amerisource Health Services LLC Published Apr 9, 2025
Risk level
Class IIMay cause a temporary or reversible health problem; slight chance of serious harm.
Severity score 55/100
What should you do?
- Check whether you have this product, using the lot codes, UPCs, and dates listed below.
- Do not eat, serve, or sell the affected product.
- Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
- Contact Amerisource Health Services LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall
cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product.
Affected products (1)
Voriconazole Tablets, 50 mg, packaged in cartons of 3 blister cards with 10 individual blistered doses (30 Unit Dose per carton), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC 60687-294-21, Unit Dose NDC 60687-294-11.
VORICONAZOLE · 889 cartons
NDC: 60687-273, 60687-294, 60687-294-11, 60687-294-21, 60687-273-11, 60687-273-21
Lot codes: 1014138
Code info: Lot # 1014138, Exp 04/30/2025
Affected areas
Nationwide
Timeline
- InitiatedMar 24, 2025
- PublishedApr 9, 2025
- TerminatedFeb 10, 2026
- Recall number
- D-0307-2025
- Agency
- U.S. Food and Drug Administration
- Country
- US
FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.