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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Topical Products

Dapsone Gel 7.5% Recalled for Product Crystallization

Agency Publication Date: November 5, 2024
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Summary

Viona Pharmaceuticals Inc. is recalling 6,048 pumps of Dapsone Gel 7.5% (dapsone), a prescription topical medication used to treat acne. The recall was issued because the medication has started to crystallize inside the pump container. This defect can prevent the gel from being dispensed correctly or affect the texture and consistency of the treatment.

Risk

Crystallization within the gel can cause the pump mechanism to clog or lead to a gritty texture that may irritate the skin. This issue can also result in an inconsistent or incorrect dose of the medication being applied.

What You Should Do

  1. The recalled product is Dapsone Gel 7.5% (dapsone) sold in 60-gram pump containers with NDC 72578-094-02.
  2. Check your medication container for lot numbers T401151 (Expiration 06/30/2026) or T400806 (Expiration 03/31/2026).
  3. 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 the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 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
๐Ÿ—‘๏ธ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, Topical Gel
Lot Numbers:
T401151 (Exp 06/30/2026)
T400806 (Exp 03/31/2026)
NDC:
72578-094-02

Rx Only. Manufactured by Zydus Lifesciences Ltd., India.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95650
Status: Active
Manufacturer: VIONA PHARMACEUTICALS INC
Sold By: Pharmacies
Manufactured In: India, United States
Units Affected: 6048 pumps
Distributed To: Nationwide

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 ยท 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.