October 2024 FDA Recall Dapsone by Viona Pharmaceuticals Inc
D-0038-2025 - Crystallization

This Class II drug recall was voluntarily initiated by Viona Pharmaceuticals Inc on October 29, 2024 for the product Dapsone. The FDA reported the reason for recall as crystallization. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0038-2025

Reason for Recall
Crystallization
Initiated
10-29-2024
Reported
11-13-2024
Quantity
6048 pumps

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
95650
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
VIONA PHARMACEUTICALS INC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA Nationwide
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# Lots T401151, Exp, 06/30/2026; T400806, Exp 03/31/2026

Affected Packages Involved in this Recall

72578-094-01 Dapsone
72578-094-02 Dapsone
72578-094-03 Dapsone