Medications & Supplements/Topical Products

Dapsone Gel 7.5% Recalled Due to Crystallization

Agency Publication Date: January 2, 2025

Summary

Viona Pharmaceuticals Inc. is recalling 26,064 packs of Dapsone Gel 7.5%, a prescription medication used to treat acne. The recall includes 60-gram and 90-gram airless pump packs manufactured by Zydus Lifesciences Ltd. because the medication has formed crystals, which can cause the product to become gritty. Using a crystallized gel may lead to an uneven dose of the medication or cause skin irritation. Consumers should consult their doctor or pharmacist regarding their treatment.

Risk

Crystallization of the gel can result in an inconsistent concentration of the active medication, potentially making the treatment less effective. It also poses a risk of localized skin irritation at the application site due to the gritty texture of the crystals.

What You Should Do

This recall affects Dapsone Gel 7.5% packaged in airless pump packs, specifically the 60-gram size (NDC 72578-094-02) and 90-gram size (NDC 72578-094-03).
Check the lot number and expiration date printed on your pump pack or carton. Affected lot numbers include T400513, T400807, T401152, T401303, T401304, T401399, T401696, T400514, and T400808 with expiration dates between February and August 2026. See the Affected Products section below for the full list of affected codes.
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.
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 g)

Variants: 7.5%, 60 g, Airless pump pack

Lot Numbers:

T400513 (Exp 02/2026)

T400807 (Exp 03/2026)

T401152 (Exp 06/2026)

T401303 (Exp 07/2026)

T401304 (Exp 07/2026)

T401399 (Exp 07/2026)

T401696 (Exp 08/2026)

NDC:

72578-094-02

Manufactured by Zydus Lifesciences Ltd., Ahmedabad, India. Distributed by Viona Pharmaceuticals Inc.

Product: Dapsone Gel 7.5% (90 g)

Variants: 7.5%, 90 g, Airless pump pack

Lot Numbers:

T400514 (Exp 02/2026)

T400808 (Exp 03/2026)

NDC:

72578-094-03

Manufactured by Zydus Lifesciences Ltd., Ahmedabad, India. Distributed by Viona Pharmaceuticals Inc.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95930

Status: Active

Manufacturer: VIONA PHARMACEUTICALS INC

Sold By: Pharmacies

Manufactured In: India, United States

Units Affected: 2 products (23304 packs; 2760 packs)

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 · 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

This recall affects Dapsone Gel 7.5% packaged in airless pump packs, specifically the 60-gram size (NDC 72578-094-02) and 90-gram size (NDC 72578-094-03).

Check the lot number and expiration date printed on your pump pack or carton. Affected lot numbers include T400513, T400807, T401152, T401303, T401304, T401399, T401696, T400514, and T400808 with expiration dates between February and August 2026. See the Affected Products section below for the full list of affected codes.

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.

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 g)

Variants: 7.5%, 60 g, Airless pump pack

Lot Numbers:

T400513 (Exp 02/2026)

T400807 (Exp 03/2026)

T401152 (Exp 06/2026)

T401303 (Exp 07/2026)

T401304 (Exp 07/2026)

T401399 (Exp 07/2026)

T401696 (Exp 08/2026)

NDC:

72578-094-02

Manufactured by Zydus Lifesciences Ltd., Ahmedabad, India. Distributed by Viona Pharmaceuticals Inc.

Product: Dapsone Gel 7.5% (90 g)

Variants: 7.5%, 90 g, Airless pump pack

Lot Numbers:

T400514 (Exp 02/2026)

T400808 (Exp 03/2026)

NDC:

72578-094-03

Manufactured by Zydus Lifesciences Ltd., Ahmedabad, India. Distributed by Viona Pharmaceuticals Inc.