Recalls / Class II
Class IID-0318-2025
Product
Voriconazole Tablets 200 mg, 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# 68462-573-30
- Brand name
- Voriconazole
- Generic name
- Voriconazole
- Active ingredient
- Voriconazole
- Route
- Oral
- NDCs
- 68462-572, 68462-573
- FDA application
- ANDA203503
- Affected lot / code info
- Lot # 17230853, exp. date Mar-25 17231271, exp. date May-25 17231300, exp. date May-25 17242050, exp. date Oct-26 17231046, exp. date Apr-25 17241156, exp. date Jun-26 17241388, exp. date Jul-26 17241800, exp. date Sep-26
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- Glenmark Pharmaceuticals Inc., USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 750 Corporate Dr, N/A, Mahwah, New Jersey 07430-2009
Distribution
- Quantity
- N/A
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2025-03-13
- FDA classified
- 2025-04-08
- Posted by FDA
- 2025-04-16
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0318-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.