Recall: D-0016-2026

Class II - Potentially Harmful

Class IIClassification

2025-10-06Initiated

OngoingStatus

VIONA PHARMACEUTICALS INCFirm

Product

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.

Reason

Discoloration

Distribution

USA Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.