FDA recall D-0595-2025

Product

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

Reason for recall

Discoloration

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2025-08-12

Report date

2025-08-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cranford, NJ, United States

Primary source

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