Unrated Drug recall · FDA · Published December 10, 2024

Viona Dapsone Gel 7.5% Recall: Crystallization Risk

Viona Pharmaceuticals recalls Dapsone Gel 7.5% (90g) due to crystallization risk. This Rx-only medication, manufactured by Zydus Lifesciences, may cause issues if stored improperly.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0172-2025Drug Viona ›

Recall notice

Crystallization

Take action

Contact the company

Recalling firmVIONA PHARMACEUTICALS INC20 Commerce Dr Ste 340 · Cranford, NJ 07016-3617

✎ GovInfoNow plain-language explainer

Viona Pharmaceuticals is recalling Dapsone Gel 7.5% (90g) because of a crystallization risk. This prescription-only medication could potentially cause problems if stored incorrectly. Read more at govinfonow.com/recall/32376-viona-dapsone-gel-7-5-recall-crystallization-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/32376-viona-dapsone-gel-7-5-recall-crystallization-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0172-2025

Cite this page

“Viona Dapsone Gel 7.5% Recall: Crystallization Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32376-viona-dapsone-gel-7-5-recall-crystallization-risk. Based on FDA recall #D-0172-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0172-2025%22&limit=1).

Viona Pharmaceuticals Inc. is voluntarily recalling Dapsone Gel 7.5% due to crystallization, the Food and Drug Administration announced on Dec. 10, 2024. The Class II recall affects 2,760 packs distributed nationwide.

How to tell if you have it

Brand: Viona
Product: Dapsone Gel 7.5%, 90 g, Rx Only
NDC: 72578-094-03
Lot codes: T400514 (Exp 02/2026), T400808 (Exp 03/2026)
Packaging: Airless pump pack
Manufacturer: Zydus Lifesciences Ltd., Ahmedabad, India
Distributor: Viona Pharmaceuticals Inc., Cranford, NJ 07016

The hazard

The recall addresses crystallization in the gel. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Viona Pharmaceuticals Inc. has six other recalls on record since June 1, 2021. Recent brand recalls include Tavaborole 5% Solution recalls for discoloration hazards on Oct. 6 and Aug. 12, 2025, and a Dapsone Gel 7.5% recall for crystallization risk on Oct. 29, 2024. Other recent recalls of similar products include Endo USA Buprenorphine Injection Recall (March 13, 2026), Par Health Buprenorphine Injection Recall (June 12, 2026), and Par Health Recalls Buprenorphine Injections Due to Crystallization (Sept. 8, 2026).

How to tell if you have this one

Check for the product name 'Dapsone Gel 7.5% (90g)' with lot numbers T400514 (expiring 02/2026) or T400808 (expiring 03/2026).

Brand
Viona
Category
Drug

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
US Nationwide
NDC
72578-094-01, 72578-094-02, 72578-094-03

Recall number	Product, codes & lots	Quantity
D-0171-2025	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; 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.	23304 packs
D-0172-2025	Dapsone Gel 7.5%, 90 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-03. packaged in an Airless pump pack; Lots T400514, Exp Date 02/2026 & T400808, Exp Date 03/2026	2760 packs

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the lot numbers T400514 or T400808 on the packaging.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 29 days after the firm started it.

Dec 10, 2024Firm started the recall
Jan 2, 2025FDA classified it Class II
Jan 8, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/32376-viona-dapsone-gel-7-5-recall-crystallization-risk">Viona Dapsone Gel 7.5% Recall: Crystallization Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0172-2025 (December 10, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0172-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.