August 2025 FDA Recall Tavaborole by Viona Pharmaceuticals Inc
D-0595-2025 - Discoloration

This Class II drug recall was voluntarily initiated by Viona Pharmaceuticals Inc on August 12, 2025 for the product Tavaborole. The FDA reported the reason for recall as discoloration. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0595-2025

Reason for Recall
Discoloration
Initiated
08-12-2025
Reported
08-27-2025
Quantity
3960 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
97424
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
VIONA PHARMACEUTICALS INC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# : T401968

Affected Packages Involved in this Recall

72578-102-04 Tavaborole