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
- Brand
- TAVABOROLE
- Lot code
- T401968
Additional details
Lot #: T401968
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 3960 bottles.
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