Why it was recalled
Discoloration
Product description
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 numbers, UPCs & expiration codes
Lot #: T401968
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0595-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Aug 12, 2025
- FDA report date
- Aug 27, 2025
- Quantity
- 3960 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- VIONA PHARMACEUTICALS INC
Original FDA data
Every field from FDA enforcement report D-0595-2025, exactly as published.
Show all FDA fields
- City
- Cranford
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 97424
- Address
- 20 Commerce Dr Ste 340
- Code information
- Lot #: T401968
- Postal code
- 07016-3617
- Report date
- Aug 27, 2025
- Product type
- Drugs
- Recall number
- D-0595-2025
- Classification
- Class II
- Recalling firm
- VIONA PHARMACEUTICALS INC
- Product quantity
- 3960 bottles
- Reason for recall
- Discoloration
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Aug 12, 2025
- Initial firm notification
- Letter
- Center classification date
- Aug 21, 2025