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 Nov 13, 2024

Risk level

Class II

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

Severity score 60/100

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 · 6048 pumps

NDC: 72578-094, 72578-094-01, 72578-094-02, 72578-094-03

Lot codes: T401151

Code info: Lots T401151, Exp, 06/30/2026; T400806, Exp 03/31/2026

Affected areas

Nationwide

Timeline

Initiated

Oct 29, 2024
Published

Nov 13, 2024

Recall number: D-0038-2025
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.