FDA-Drug2025-08-27Class II

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

VIONA PHARMACEUTICALS INC
Hazard

Discoloration

Sold states
Nationwide in the USA
Affected count
3960 bottles
Manufactured in
20 Commerce Dr Ste 340, N/A, Cranford, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0595-2025

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief