FDA Drugs recall ·
Tavaborole Topical Solution 5%, 10 mL per glass bottle, Rx Only… recall
- Recall number
- D-0595-2025
- Date
- (initiated August 12, 2025)
- Company / brand
- Viona Pharmaceuticals Inc
20 Commerce Dr Ste 340, Cranford, NJ, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 3960 bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Discoloration
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: T401968
Distribution
Nationwide in the USA
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0595-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.