Glenmark Recalls Azelaic Acid Gel Due to Gritty Texture
Glenmark Pharmaceuticals is recalling 13,824 tubes of Azelaic Acid Gel 15% due to CGMP deviations causing a gritty texture. Check your batch number.
Lower-risk recall
CGMP Deviations: Market complaints received for gritty texture (grainy)
Contact the company
What happened, in plain English
Glenmark Pharmaceuticals Inc., USA has recalled one lot of Azelaic Acid Gel, 15%, because market complaints indicated the product had a gritty or grainy texture. This recall is classified as Class II and affects 13,824 tubes distributed nationwide in the United States. The record does not specify any physical injury associated with this defect. Read more at govinfonow.com/recall/31779-glenmark-recalls-azelaic-acid-gel-due-to-gritty-texture.
Source Summary by GovInfoNow · govinfonow.com/recall/31779-glenmark-recalls-azelaic-acid-gel-due-to-gritty-texture · Updated October 9, 2026 · FDA enforcement record: FDA #D-0662-2025
Cite this page
“Glenmark Recalls Azelaic Acid Gel Due to Gritty Texture.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/31779-glenmark-recalls-azelaic-acid-gel-due-to-gritty-texture. Based on FDA recall #D-0662-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0662-2025%22&limit=1).
Why it’s dangerous
The hazard is a manufacturing deviation resulting in a gritty texture rather than a smooth gel. The record does not describe any mechanism for physical injury, such as skin damage or systemic toxicity, associated with this textural defect.
Who’s affected
Consumers who purchased Azelaic Acid Gel, 15% from pharmacies or retailers across the United States between unspecified dates prior to September 17, 2025. Users of this prescription topical medication are the primary group affected.
How to tell if you have this one
Check your tube for the following details: Product name Azelaic Acid Gel, 15%, 50 grams; NDC 68462-626-52; Batch # 19252524; Expiration Date May 2027. The product is manufactured by Glenmark Pharmaceuticals Limited in India for Glenmark Pharmaceuticals Inc., USA.
- Brand
Glenmark Pharmaceuticals- Category
Drug
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 14 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Similar recalls
Other Glenmark Pharmaceuticals recalls
Latest drug recalls
Keep exploring
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-0662-2025 (September 17, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0662-2025 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 9, 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.