Recall
FDAHealthAugust 12, 2025

VIONA PHARMACEUTICALS INC — 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

⚠️ Discoloration

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
August 12, 2025

Nationwide in the USA

What's affected?

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
Lot code
T401968

Additional details

Lot #: T401968

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 3960 bottles.

View original FDA notice →

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