Dapsone Gel
FDA Recall NDC 72578-094
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 4 recorded enforcement report(s) associated with Dapsone (NDC 72578-094). A significant event, classified as Class II, was initiated on Dec 10, 2024 by Viona Pharmaceuticals Inc. The reported reason for this action was: "Crystallization"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Crystallization
Dec 10, 2024
Jan 08, 2025
23304 packs
Recall Profile & Regulatory Data
Event ID
95930
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
VIONA PHARMACEUTICALS INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide
Product Description
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
Batch or Lot Expiration Information
Lot# 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.
Affected Packages Involved in this Recall
72578-094-01Product
72578-094-02Product
72578-094-03Product
Class II Ongoing
Crystallization
Dec 10, 2024
Jan 08, 2025
2760 packs
Recall Profile & Regulatory Data
Event ID
95930
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
VIONA PHARMACEUTICALS INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide
Product Description
Dapsone Gel 7.5%, 90 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-03. packaged in an Airless pump pack
Batch or Lot Expiration Information
Lot# Lots T400514, Exp Date 02/2026 & T400808, Exp Date 03/2026
Affected Packages Involved in this Recall
72578-094-01Product
72578-094-02Product
72578-094-03Product
Class II Ongoing
Crystallization
Oct 29, 2024
Nov 13, 2024
6048 pumps
Recall Profile & Regulatory Data
Event ID
95650
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
VIONA PHARMACEUTICALS INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Product Description
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
72578-094-01Product
72578-094-02Product
72578-094-03Product
Class II Ongoing
Crystallization
Sep 24, 2024
Oct 23, 2024
2544 pumps
Recall Profile & Regulatory Data
Event ID
95412
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
VIONA PHARMACEUTICALS INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
NY
Product Description
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# : T400512, Exp 02/28/2026
Affected Packages Involved in this Recall
72578-094-01Product
72578-094-02Product
72578-094-03Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
