Medications & Supplements/Topical Products

Dapsone Gel 7.5% Recalled for Crystallization

Agency Publication Date: October 12, 2024

Summary

Viona Pharmaceuticals Inc. has recalled approximately 2,544 pumps of Dapsone Gel 7.5% (60 gram pumps) due to crystallization of the medicine. The recall affects Lot T400512 of this prescription acne treatment. Consumers should check their product label for the specific lot number and an expiration date of February 2026.

Risk

Crystallization of the gel can lead to an uneven distribution of the active ingredient, potentially causing skin irritation or making the medication less effective at treating acne.

What You Should Do

The recalled product is Dapsone Gel 7.5% in 60 gram pumps (NDC 72578-094-02), specifically lot number T400512 with an expiration date of 02/28/2026.
Check the pump label or the outer carton to find the lot number and expiration date to determine if your product is affected.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Viona Pharmaceuticals Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Dapsone Gel 7.5% (60 gram pump)

Variants: 7.5% Strength, 60 gram pump, Rx Only

Lot Numbers:

T400512 (Exp 02/28/2026)

NDC:

72578-094-02

Manufactured by Zydus Lifesciences Ltd. in India; Distributed by Viona Pharmaceuticals Inc. in NJ.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95412

Status: Active

Manufacturer: VIONA PHARMACEUTICALS INC

Sold By: Pharmacies

Manufactured In: India, United States

Units Affected: 2544 pumps

Distributed To: New York

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

The recalled product is Dapsone Gel 7.5% in 60 gram pumps (NDC 72578-094-02), specifically lot number T400512 with an expiration date of 02/28/2026.

Check the pump label or the outer carton to find the lot number and expiration date to determine if your product is affected.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Viona Pharmaceuticals Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.