FDA Recall D-0595-2025
VIONA PHARMACEUTICALS INC · Cranford, NJ
Class II Ongoing 275 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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
Reason for recall
Discoloration
Recall record
- Recall number
D-0595-2025- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA
- Recall initiated
- 2025-08-12
- Classified by FDA Center
- 2025-08-21
- FDA published
- 2025-08-27
- Recalling firm
- VIONA PHARMACEUTICALS INC
- Firm location
- Cranford, NJ
Drug identification
- Brand name(s)
- TAVABOROLE
- Generic name(s)
- TAVABOROLE
- Manufacturer(s)
- Viona Pharmaceuticals Inc
- NDC(s)
72578-102- Route(s)
- TOPICAL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.