Reported Jan 8, 2025 · Ongoing

Dapsone Gel 7.5%, 60 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahemedabad, India, Distributed by: Viona…

Viona Pharmaceuticals Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: VIONA PHARMACEUTICALS INC · 20 Commerce Dr Ste 340 · Cranford, NJ · 07016-3617

Is this the product you have?

    • Dapsone Gel 7.5%
    • 60 g
    • Rx Only
  • Manufactured byZydus Lifesciences Ltd., Ahemedabad, India
  • Distributed byViona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02. packaged in an Airless pump pack
Lot codes and dates
    • 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
Amount recalled
23304 packs

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

  • Nationwide

Why it was recalled

Crystallization

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 8:03 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.