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Class II · ModerateActive recall

Voriconazole

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot # 17231045, exp. date Apr-25
Where it was soldU.S. Nationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

CGMP Deviations

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byGlenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430 foreign manufacturer
Brand nameVORICONAZOLE
Generic nameVORICONAZOLE
Active ingredient(s)VORICONAZOLE
Distributed by / forGlenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430
NDC68462-572-30
Show the full FDA record
Full product labelVoriconazole Tablets 50mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-572-30.
Recalling firmGlenmark Pharmaceuticals Inc., USA
DistributionU.S. Nationwide
QuantityN/A
Recall initiated2025-03-13
Report date2025-04-16
Recall completed
Recall numberD-0319-2025
ClassificationClass II
FDA statusOngoing
Origin on fileMahwah NJ United States

Related

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.