Recalls / Class II
Class IID-0595-2025
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 name
- Tavaborole
- Generic name
- Tavaborole
- Active ingredient
- Tavaborole
- Route
- Topical
- NDC
- 72578-102
- FDA application
- ANDA212294
- Affected lot / code info
- Lot #: T401968
Why it was recalled
Discoloration
Recalling firm
- Firm
- VIONA PHARMACEUTICALS INC
- Manufacturer
- Viona Pharmaceuticals Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 20 Commerce Dr Ste 340, N/A, Cranford, New Jersey 07016-3617
Distribution
- Quantity
- 3960 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2025-08-12
- FDA classified
- 2025-08-21
- Posted by FDA
- 2025-08-27
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0595-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.