FDA Drug · D-0595-2025

Tavaborole Topical Solution 5%, 10 mL per glass bottle, Rx Only, For Topical Use Only, Manufactured by: Zydus Lifesciences Ltd., Changodar Ahmedabad, India. Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016. NDC: 72578-102-04

Class II · Ongoing

Discoloration

Affected lots / codes — check yours against thisLot #: T401968

Recalling firm: VIONA PHARMACEUTICALS INC, Cranford, NJ
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 3960 bottles
Distribution: Nationwide in the USA
Recall initiated: August 12, 2025
Classified: August 21, 2025
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0595-2025%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

Check this brand across all 8 databases →