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.

Recall Number: D-0016-2026

Firm: VIONA PHARMACEUTICALS INC

Classification: Class II

Status: Ongoing

Report Date: 20251022

Initiation Date: 20251006

Termination Date:

Reason for Recall

Discoloration

Product Description

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.