Zydus Lifesciences recalled 13,080 bottles of Tavaborole topical solution on October 6, 2025, due to discoloration. The recall affects products distributed nationwide in the USA. Consumers must stop using the product immediately and contact their healthcare providers 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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The recall involves Tavaborole topical solution 5%, in 10 mL bottles. The affected lot numbers include T400819, T400820, and T401969. The expiration dates are April 30, 2026, and September 30, 2026.
The discoloration of Tavaborole solution raises concerns about the product's effectiveness and safety. The FDA classified the recall as Class II, indicating a potential for serious health consequences.
As of the recall date, there are no reported injuries or incidents associated with the discoloration of the product. The company urges consumers to take this matter seriously.
Consumers should stop using the recalled Tavaborole topical solution immediately. Contact Viona Pharmaceuticals Inc. or your healthcare provider for further guidance.
For more information, contact Viona Pharmaceuticals Inc. at their Cranford, NJ office or visit the FDA's recall page at the provided URL.
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