Voriconazole Tablets recall
FDA recall D-0307-2025 · initiated Mar 24, 2025
Amerisource Health Services LLC recalled Voriconazole Tablets in Mar 2025 — an FDA Class II recall (D-0307-2025) because cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product.
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: 889 cartons
Details
- Product
- 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.
- Recalling company
- Amerisource Health Services LLC
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- USA nationwide.
- Initiated
- Mar 24, 2025
- FDA report date
- Apr 9, 2025
Frequently asked
- Was Voriconazole Tablets recalled?
- Amerisource Health Services LLC recalled Voriconazole Tablets in Mar 2025 — an FDA Class II recall (D-0307-2025) because cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Voriconazole Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0307-2025 was: cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product.
- Is a recalled Voriconazole 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 Voriconazole Tablets are affected?
- Distributed: USA nationwide.. The recall covers these lots — Lot # 1014138, Exp 04/30/2025. 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-0307-2025.