Voriconazole Antifungal Drug Recalled for Manufacturing Deviations
Aspen Biopharma Labs is voluntarily recalling Voriconazole, an antifungal medication, due to manufacturing process deviations. The product was distributed to three distributors in Hong Kong and Florida.
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 Class II drug recall without reported illnesses or injuries. The recall is voluntary and based on manufacturing process deviations, making it a precautionary action with theoretical rather than confirmed hazard.
Plain-English summary
Aspen Biopharma Labs Pvt., Ltd. is voluntarily recalling Voriconazole, an antifungal medication, due to Current Good Manufacturing Practice (CGMP) deviations. The recall was initiated on February 7, 2025.
The affected product is Voriconazole with Lot Number HAVZC0020922 and an expiration date of August 2026. The quantity involved is 4.0 kg, packed in white and black poly bags inside HDPE containers. The product was distributed to three distributors: one located in Hong Kong and two accounts in Florida.
The FDA has classified this as a Class II recall, and the recall status remains ongoing as of the report date.
The recalled product
- Product
- Voriconazole Container Description: voriconazole The product packed in white poly bag containing black poly bag and tied each individual finally packed in HDPE container for shipping.
- Manufacturer
- Aspen Biopharma Labs Pvt., Ltd.
- Category
- Drug — Antifungal
- Hazard
- manufacturing-process-violation
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 Number: HAVZC0020922
- exp. date AUG-2026
Distribution
Distribution scope not specified by the agency.
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