FDA recall D-0016-2026

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 for recall

Discoloration

Distribution

USA Nationwide

Key facts

Status

Ongoing

Initiation date

2025-10-06

Report date

2025-10-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cranford, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0016-2026