Viona Pharmaceuticals recalled 13,080 Tavaborole Topical Solution 5%, 10 mL bottles distributed nationwide in the United States. The recall covers Tavaborole Topical Solution 5%, Rx only, manufactured by Zydus Lifesciences Ltd. Discoloration linked to RES #97424 prompted the action. Consumers should stop using the product and contact Viona for guidance.
Discoloration - Expansion of RES #97424
Consumers and healthcare providers should stop using this product immediately. Contact VIONA PHARMACEUTICALS INC or your healthcare provider for guidance. Notification method: Letter
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Tavaborole Topical Solution 5% is a prescription antifungal treatment in a 10 mL bottle. It is used to treat fungal infections of the nails. The recalled product is distributed nationwide in the United States.
Discoloration is identified as a manufacturing quality issue tied to RES #97424. The label indicates a potential defect in the product that could affect appearance or integrity.
This recall is not described as part of a broader industry pattern.
Consumers must stop using the product until guidance is provided. The recall affects a limited number of bottles but requires action to avoid continuing use of a potentially defective product.
Recall details can be found on the FDA enforcement page and through Viona Pharmaceuticals. Check the label for NDC and model numbers.
Remedy processing timelines were not specified. Expect guidance from the company within weeks.
Keep the product packaging, recall notice, and any correspondence with the company for future reference.
Model numbers: T400819, T400820, T401969. NDC 72578-102-04. Rx only. Manufactured by Zydus Lifesciences Ltd., Changodar, Ahmedabad, India. Distributed by Viona Pharmaceuticals Inc., Cranford, NJ 07016. Quantity: 13,080 bottles. Distribution: USA nationwide. Recall date: 2025-10-06. Status: ACTIVE.
No injuries or incidents have been reported.
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