Tavaborole Topical Solution 5%, 10 mL per glass bottle, Rx Only, For Topical Use Only, Manufactured by: Zydus Lifescienc
Summary
The FDA issued a Class II for Tavaborole Topical Solution 5%, 10 mL per glass bottle, Rx Only, For Topical Use by VIONA PHARMACEUTICALS INC. Reason: Discoloration.
Details
Source
Drug Recall
External ID
D-0595-2025
Action Date
2025-08-27
Status
Ongoing
Category
drug
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
Lot/Code Info: Lot #: T401968
Quantity Affected: 3960 bottles
Reason for Recall
Discoloration
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2025-08-12
Company
Cranford, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 48 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
VIONA PHARMACEUTICALS INC has 7 FDA actions in our database, including 7 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (VIONA PHARMACEUTICALS INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does VIONA PHARMACEUTICALS INC have FDA actions?
VIONA PHARMACEUTICALS INC has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0595-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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