Recall: D-0171-2025

Class II - Potentially Harmful

Class IIClassification

2024-12-10Initiated

OngoingStatus

VIONA PHARMACEUTICALS INCFirm

Product

Dapsone Gel 7.5%, 60 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahemedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02. packaged in an Airless pump pack

Reason

Crystallization

Distribution

US Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.