FDA Drug · D-0016-2026

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.

Class II · Ongoing

Discoloration

Affected lots / codes — check yours against thisLot#: T400819, T400820, Exp 4/30/26; T401969, Exp 9/30/26

Recalling firm: VIONA PHARMACEUTICALS INC, Cranford, NJ
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 13080 bottles
Distribution: USA Nationwide
Recall initiated: October 6, 2025
Classified: October 10, 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-0016-2026%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.

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