Glenmark Azelaic Acid Gel Recall: CGMP Deviations
Glenmark Pharmaceuticals recalls 14,004 cartons of Azelaic Acid Gel 15% due to CGMP deviations. Check your lot number and expiration date.
Recall notice
CGMP Deviations
Contact the company
What happened, in plain English
Glenmark Pharmaceuticals Inc., USA is recalling one lot of Glenmark Azelaic Acid Gel, 15%, 50 grams because it was manufactured with Current Good Manufacturing Practice (CGMP) deviations. The product is prescription-only and was distributed nationwide across the U.S. No specific remedy or injury details are provided in this record. Read more at govinfonow.com/recall/32582-glenmark-azelaic-acid-gel-recall-cgmp-deviations.
Source Summary by GovInfoNow · govinfonow.com/recall/32582-glenmark-azelaic-acid-gel-recall-cgmp-deviations · Updated October 9, 2026 · FDA enforcement record: FDA #D-0621-2024
Cite this page
“Glenmark Azelaic Acid Gel Recall: CGMP Deviations.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/32582-glenmark-azelaic-acid-gel-recall-cgmp-deviations. Based on FDA recall #D-0621-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0621-2024%22&limit=1).
Why it’s dangerous
The recall is due to CGMP deviations, which means the manufacturing process did not meet federal quality standards. The record does not specify what these deviations were or if they resulted in product contamination or potency issues, so the specific danger mechanism is unknown.
Who’s affected
Consumers who purchased the recalled prescription gel from pharmacies or retailers nationwide between its release and the recall date. Individuals using this medication for skin conditions are the primary group affected.
How to tell if you have this one
Check your tube for the brand name 'Glenmark', the description 'Azelaic Acid Gel, 15 %, 50 grams', and the NDC number 68462-626-52. Verify that the lot number is 19241453 and the expiration date is MARCH 2026.
- Brand
Glenmark- Category
Drug
What to do — step by step
Check Your Product Details
Verify if your Azelaic Acid Gel matches the recalled lot number 19241453 and NDC 68462-626-52.
Consult Your Pharmacist
Contact your pharmacy or healthcare provider to determine the next steps for this prescription medication.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “U.S. 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 16 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.
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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-0621-2024 (July 22, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0621-2024 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.