March 2025 FDA Recall Voriconazole by Amerisource Health Services Llc
D-0307-2025 - cGMP Deviations

This Class II drug recall was voluntarily initiated by Amerisource Health Services Llc on March 24, 2025 for the product Voriconazole. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0307-2025

Reason for Recall
cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product.
Initiated
03-24-2025
Reported
04-09-2025
Quantity
889 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
96574
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Amerisource Health Services LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2026
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# 1014138, Exp 04/30/2025

Affected Packages Involved in this Recall

60687-294-11 Voriconazole
60687-294-21 Voriconazole
60687-273-11 Voriconazole
60687-273-21 Voriconazole