FDA Recall D-0171-2025

VIONA PHARMACEUTICALS INC · Cranford, NJ

Class II Ongoing 520 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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

Lot / code: 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.

Quantity: 23304 packs

Reason for recall

Crystallization

Recall record

Recall number: D-0171-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: US Nationwide
Recall initiated: 2024-12-10
Classified by FDA Center: 2025-01-02
FDA published: 2025-01-08
Recalling firm: VIONA PHARMACEUTICALS INC
Firm location: Cranford, NJ

Drug identification

Brand name(s): DAPSONE
Generic name(s): DAPSONE
Manufacturer(s): Viona Pharmaceuticals Inc
NDC(s): 72578-094
Route(s): TOPICAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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