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D-0172-2025Class II

VIONA PHARMACEUTICALS INC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
VIONA PHARMACEUTICALS INC
Product type
Drug
Status
Ongoing
Report date
2025-01-08
Distribution
US Nationwide
Firm state
NJ
Product quantity
2760 packs
Initiated by
Voluntary: Firm initiated
Reason for recall

Crystallization

Product description

Dapsone Gel 7.5%, 90 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-03. packaged in an Airless pump pack

Code / lot info

Lots T400514, Exp Date 02/2026 & T400808, Exp Date 03/2026

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →