Recalling firm
VIONA PHARMACEUTICALS INC
Product type
Drug
Status
Ongoing
Report date
2025-10-22
Distribution
USA Nationwide
Firm state
NJ
Product quantity
13080 bottles
Initiated by
Voluntary: Firm initiated
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.
Code / lot info
Lot#: T400819, T400820, Exp 4/30/26; T401969, Exp 9/30/26
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.