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.
Reported: October 22, 2025 Initiated: October 6, 2025 #D-0016-2026
Product Description
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.
Reason for Recall
Discoloration
Details
- Recalling Firm
- VIONA PHARMACEUTICALS INC
- Units Affected
- 13080 bottles
- Distribution
- USA Nationwide
- Location
- Cranford, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by VIONA PHARMACEUTICALS INC. Units affected: 13080 bottles.
Why was this product recalled? ▼
Discoloration
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 22, 2025. Severity: Moderate. Recall number: D-0016-2026.
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