FDAFDA · Food and drugs·Recall number D-0016-2026
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.
Published October 22, 2025 · Recall initiated: October 6, 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
- USA Nationwide
- Lot
- Lot#: T400819, T400820, Exp 4/30/26; T401969, Exp 9/30/26
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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