Tavaborole Topical solution 5%, 10 mL bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Changodar, Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-102-04.

FDA recall notice · announced October 22, 2025 · Viona Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Tavaborole Topical solution 5%, 10 mL bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Changodar, Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-102-04.

Reason for recall

Discoloration

Notes

Distribution: USA Nationwide
Lot/code information: Lot#: T400819, T400820, Exp 4/30/26; T401969, Exp 9/30/26
Quantity: 13080 bottles
Status: Ongoing
Products in this recall event:
- Tavaborole Topical solution 5%, 10 mL bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Changodar, Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578- (D-0016-2026)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.