FDAHealthOctober 6, 2025
VIONA PHARMACEUTICALS INC — Tavaborole Topical solution 5%, 10 mL bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Changodar, Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cr
⚠️ Discoloration
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- October 6, 2025
USA Nationwide
What's affected?
- 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.
- Brand
- TAVABOROLE
- Lot code
- T400819
Additional details
Lot#: T400819, T400820, Exp 4/30/26; T401969, Exp 9/30/26
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 13080 bottles.
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