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
Reported: August 27, 2025 Initiated: August 12, 2025 #D-0595-2025
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
Reason for Recall
Discoloration
Details
- Recalling Firm
- VIONA PHARMACEUTICALS INC
- Units Affected
- 3960 bottles
- Distribution
- Nationwide in the USA
- Location
- Cranford, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by VIONA PHARMACEUTICALS INC. Units affected: 3960 bottles.
Why was this product recalled? ▼
Discoloration
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 27, 2025. Severity: Moderate. Recall number: D-0595-2025.
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