Class IIReported 2025-10-22

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.

Recalled by VIONA PHARMACEUTICALS INC

Reason for Recall

Discoloration

Recall Number

D-0016-2026

Classification

Class II

Status

Ongoing

Category

drug

Initiated

2025-10-06

Reported

2025-10-22

Distribution

USA Nationwide

Code Info

Lot#: T400819, T400820, Exp 4/30/26; T401969, Exp 9/30/26

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.