Viona Pharmaceuticals recalls Tavaborole Topical Solution 5% 10 mL bottles, distributed nationwide in the U.S. The effective recall date is August 12, 2025. The product is manufactured by Zydus Lifesciences Ltd. Discoloration was cited as the reason for the recall. Consumers should stop using the product and contact the distributor for guidance.
Discoloration
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 used for fungal infections. It is supplied in glass bottles and distributed nationwide.
Discoloration triggers the recall; the specific impact on safety beyond labeling is not provided in the notice.
This recall is not described as part of a broader industry pattern in the provided data.
The recall affects patient trust and requires clinicians and pharmacies to review stock and substitutions. The immediate action is to stop use and consult the distributor.
NDC and model numbers on bottle, box, or accompanying labeling. Distributor communications will provide further instructions.
Refund or replacement processing times to be communicated by the distributor; expect several weeks for processing after submission.
Keep packaging, bottle, receipts, and recall notice. Document all communications with the distributor.
Product: Tavaborole Topical Solution 5%, 10 mL per glass bottle. Brand: Tavaborole. Generic: Tavaborole. NDC: 72578-102-04. Manufactured by: Zydus Lifesciences Ltd., Changodar, Ahmedabad, India. Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016. Quantity recalled: 3,960 bottles. Distribution: Nationwide in the USA. Recall date: 2025-08-12. Classification: Class II recall. Hazard: Discoloration.
No injuries or incidents have been reported.
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