Voriconazole Tablets 50mg Recalled Due to CGMP Deviations
Glenmark Pharmaceuticals Inc. USA is recalling Voriconazole Tablets 50mg (Lot # 17231045, exp. date Apr-25) distributed nationwide due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall for CGMP deviations. The source text does not report any illnesses, injuries, or confirmed adverse health consequences. Per the rubric, CGMP deviations without reported harm typically fall into the Moderate category.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Voriconazole Tablets 50mg, 30-count bottles (NDC# 68462-572-30 and related package sizes) distributed nationwide. The recall affects Lot # 17231045 with an expiration date of April 2025.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations identified at the manufacturing facility. CGMP deviations can affect the quality and safety of pharmaceutical products.
The product was manufactured by Glenmark Pharmaceuticals Limited in Pithampur, Madhya Pradesh, India, and manufactured for Glenmark Pharmaceuticals Inc., USA in Mahwah, NJ. The recall is ongoing as of the latest report date.
Patients who have this medication should consult their physician or pharmacist before taking any action. Do not stop taking the medication without medical guidance, as voriconazole is a prescription antifungal medication used to treat serious fungal infections.
The recalled product
- Product
- VORICONAZOLE (VORICONAZOLE)
- Brand
- VORICONAZOLE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Antifungal / Prescription
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 17231045
- exp. date Apr-25
UPCs (1)
- 0368462573303
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 39 recalled by Glenmark Pharmaceuticals Inc., USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 39 products in this recall →Related recalls
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