Recalls / Class II
Class IID-0016-2026
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 name
- Tavaborole
- Generic name
- Tavaborole
- Active ingredient
- Tavaborole
- Route
- Topical
- NDC
- 72578-102
- FDA application
- ANDA212294
- Affected lot / code info
- Lot#: T400819, T400820, Exp 4/30/26; T401969, Exp 9/30/26
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, Cranford, New Jersey 07016-3617
Distribution
- Quantity
- 13080 bottles
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2025-10-06
- FDA classified
- 2025-10-10
- Posted by FDA
- 2025-10-22
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0016-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.