US Drug Recall Register
Class II · Moderate risk Ongoing Initiated Mar 13, 2025 (1 years ago)

Voriconazole Tablets 200 mg

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

CGMP Deviations

What was recalled

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

Recalling firm
Glenmark Pharmaceuticals Inc., USA
NDC code
68462-573-30
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0318-2025

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Voriconazole recalls

See all
Class II · Moderate risk Terminated

Voriconazole Tablets

Reason cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product.

Amerisource Health Services LLC NDC 60687-294-21 D-0307-2025
Class II · Moderate risk Ongoing

Voriconazole Tablets 50mg

Reason CGMP Deviations

Glenmark Pharmaceuticals Inc., USA NDC 68462-572-30 D-0319-2025
Class II · Moderate risk Terminated

Voriconazole for Oral Suspension

Reason Labeling: Incorrect or Missing Package Insert

Lupin Pharmaceuticals Inc. D-0337-2024
Class II · Moderate risk Terminated

Voriconazole 10mg/Ml

Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Pharmacy Innovations D-0243-2023