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Class II: temporary or reversible health riskOngoing

Viona Pharmaceuticals Dapsone Gel 7 Recall

Dapsone Gel 7

VIONA PHARMACEUTICALS INC · Cranford, NJ

Risk level
Class II
Reported by FDA
Nov 13, 2024
Recall ID
D-0038-2025
Check your lot numberHow we source this data

Summary

Viona Pharmaceuticals recalled Dapsone Gel 7 starting Oct 29, 2024. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0038-2025 on Nov 13, 2024. Reason: Crystallization. Status: Ongoing.

Why it was recalled

Crystallization

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.

Lot numbers, UPCs & expiration codes

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

Where it was sold

USA Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0038-2025
Classification
Class II
Status
Ongoing
Recall initiated
Oct 29, 2024
FDA report date
Nov 13, 2024
Quantity
6048 pumps
Recall type
Voluntary: Firm initiated
Recalling firm
VIONA PHARMACEUTICALS INC

Original FDA data

Every field from FDA enforcement report D-0038-2025, exactly as published.

Show all FDA fields
City
Cranford
State
NJ
Status
Ongoing
Country
United States
Event ID
95650
Address
20 Commerce Dr Ste 340
Code information
Lots T401151, Exp, 06/30/2026; T400806, Exp 03/31/2026
Postal code
07016-3617
Report date
Nov 13, 2024
Product type
Drugs
Recall number
D-0038-2025
Classification
Class II
Recalling firm
VIONA PHARMACEUTICALS INC
Product quantity
6048 pumps
Reason for recall
Crystallization
Voluntary / mandated
Voluntary: Firm initiated
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.
Distribution pattern
USA Nationwide
Recall initiation date
Oct 29, 2024
Initial firm notification
Letter
Center classification date
Nov 5, 2024

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0038-2025, published Nov 13, 2024. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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