Glenmark Voriconazole Tablets Recalled for Manufacturing Process Deviations
Glenmark Pharmaceuticals is recalling Voriconazole 50mg tablets nationwide due to manufacturing process deviations. The prescription antifungal drug was voluntarily recalled after detecting current good manufacturing practice violations.
What this means for you
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 a FDA Class II voluntary, firm-initiated recall with no reported illnesses, injuries, or adverse events. The recall is for manufacturing process deviations (CGMP violations) without identification of a specific safety hazard. Per the severity rubric, voluntary precautionary recalls are classified as Moderate (score 2).
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Voriconazole 50mg tablets (Lot # 17231045, expiration April 2025) distributed nationwide in the United States. The product is a prescription oral antifungal medication in 30-count bottles with NDC# 68462-572-30.
The recall was initiated due to current good manufacturing practice (CGMP) deviations at the manufacturing facility. Glenmark identified manufacturing process violations and voluntarily initiated this recall on March 13, 2025. The FDA classified this as a Class II recall on April 8, 2025, and the recall is ongoing.
Patients who have received bottles from the recalled lot should contact their healthcare provider or pharmacy, providing the lot number (17231045) and expiration date (April 2025) when inquiring if their medication is affected.
Do not discontinue this medication without consulting your healthcare provider, who can advise on appropriate alternatives or next steps.
The recalled product
- Product
- VORICONAZOLE (VORICONAZOLE)
- Brand
- VORICONAZOLE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Antifungal medication
- Hazard
- cgmp-deviation
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.
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