← FDA ENFORCEMENT
D-0595-2025Class II

VIONA PHARMACEUTICALS INC

Recalling firm
VIONA PHARMACEUTICALS INC
Product type
Drug
Status
Ongoing
Report date
2025-08-27
Distribution
Nationwide in the USA
Firm state
NJ
Product quantity
3960 bottles
Initiated by
Voluntary: Firm initiated
Reason for recall

Discoloration

Product description

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

Code / lot info

Lot #: T401968

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.