Class IIReported 2025-01-08

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

Recalled by VIONA PHARMACEUTICALS INC

Reason for Recall

Crystallization

Recall Number

D-0171-2025

Classification

Class II

Status

Ongoing

Category

drug

Initiated

2024-12-10

Reported

2025-01-08

Distribution

US Nationwide

Code Info

Lots T400513, Exp Date 02/2026; T400807, Exp Date 03/2026; T401152, Exp Date 06/2026; T401303, Exp Date 07/2026; T401304, Exp Date 07/2026; T401399, Exp Date 07/2026 & T401696 Exp Date 08/2026.

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.