FDAFDA · Food and drugs·Recall number D-0595-2025
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
Published August 27, 2025 · Recall initiated: August 12, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Discoloration
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- TAVABOROLE
- Manufacturer
- VIONA PHARMACEUTICALS INC
- Distributor
- Nationwide in the USA
- Lot
- Lot #: T401968
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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