Skip to content
Back to recalls
Drug FDA Class II Ongoing Quality

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.

VIONA PHARMACEUTICALS INC Published Oct 23, 2024

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 50/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact VIONA PHARMACEUTICALS INC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Crystallization

Affected products (1)

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.

DAPSONE · 2544 pumps

NDC: 72578-094, 72578-094-01, 72578-094-02, 72578-094-03
Code info: Lot #: T400512, Exp 02/28/2026

Affected areas

New York

Timeline

  1. Initiated
    Sep 24, 2024
  2. Published
    Oct 23, 2024
Recall number
D-0011-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.