Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Vio
Summary
The FDA issued a Class II for Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd by VIONA PHARMACEUTICALS INC. Reason: Crystallization.
Details
Source
Drug Recall
External ID
D-0038-2025
Action Date
2024-11-13
Status
Ongoing
Category
drug
Product Description
Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02.
Lot/Code Info: Lots T401151, Exp, 06/30/2026; T400806, Exp 03/31/2026
Quantity Affected: 6048 pumps
Reason for Recall
Crystallization
Distribution
USA Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2024-10-29
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 35 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-0038-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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