Lower risk Drug recall · FDA · Published July 23, 2026

Glenmark Azelaic Acid Gel 15% Recall: Grainy Texture Risk

Glenmark Pharmaceuticals recalls 15% Azelaic Acid Gel tubes with grainy texture. Product quality complaints reported for abnormal consistency. Check NDC 68462-626-52 and lot numbers for affected items.

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

🇺🇸 FDA recall #D-0731-2026Drug Glenmark ›

Lower-risk recall

CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.

✎ GovInfoNow plain-language explainer

Glenmark Pharmaceuticals is recalling 15% azelaic acid gel tubes that have been reported to have grainy, gritty, or sandy texture. This quality issue could cause discomfort or irritation when applied to the skin. Read more at govinfonow.com/recall/164197-glenmark-azelaic-acid-gel-15-recall-grainy-texture-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/164197-glenmark-azelaic-acid-gel-15-recall-grainy-texture-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0731-2026

Cite this page

“Glenmark Azelaic Acid Gel 15% Recall: Grainy Texture Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/164197-glenmark-azelaic-acid-gel-15-recall-grainy-texture-risk. Based on FDA recall #D-0731-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0731-2026%22&limit=1).

The FDA announced on July 23, 2026, that Glenmark Pharmaceuticals Inc., USA is recalling Azelaic Acid Gel, 15% due to CGMP deviations resulting in abnormal texture. The agency classified the recall as Class II.

How to tell if you have it

Brand: Glenmark
Product: Azelaic Acid Gel, 15%, 50 gram tubes
NDC: 68462-626-52
Lot codes: 19260937A (Exp. Feb 2028); 19261225A, 19261185A (Exp. Mar 2028); 19261664A, 19261682A (Exp. Apr 2028)
Distribution: Nationwide within the United States

The hazard

The FDA stated that product quality complaints concerning abnormal texture or consistency, described as grainy, gritty, or sandy, were received regarding this recall.

Context

GovInfoNow's records show Glenmark Pharmaceuticals Inc., USA has 54 other recalls on record since November 20, 2017. Other recent recalls of similar products include Sun Pharmaceutical Diclofenac Gel Recall (January 27, 2026), Keystone Pearson Topical Anesthetic Gel Recall (May 21, 2026) and Keystone DHP Topical Anesthetic Gel Recall (May 21, 2026).

How to tell if you have this one

Check for the product name 'Azelaic Acid Gel, 15%, 50 gram tubes' with NDC 68462-626-52. Look for lot numbers 19260937A, 19261225A, 19261185A, 19261664A, or 19261682A.

Brand
Glenmark
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the NDC number 68462-626-52 and lot numbers listed in the recall notice.

Where it went and when

Where it was distributed

Distributed nationwide.

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

Distributed nationwide.

Recall timeline

FDA published this recall 13 days after the firm started it.

Jul 23, 2026Firm started the recall
Jul 28, 2026FDA classified it Class II
Aug 5, 2026Published in FDA’s Enforcement Report
Aug 11, 2026Added to GovInfoNow

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

Similar recalls

Other Glenmark recalls

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Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/164197-glenmark-azelaic-acid-gel-15-recall-grainy-texture-risk">Glenmark Azelaic Acid Gel 15% Recall: Grainy Texture 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-0731-2026 (July 23, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0731-2026 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.