Quick Facts at a Glance
- Recall Date
- July 23, 2026
- Hazard Level
- HIGH
- Brands
- AZELAIC ACID, Glenmark Pharmaceuticals Inc., USA
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- AZELAIC ACID, Glenmark Pharmaceuticals Inc., USA
- Model numbers
- Lot #: 19260937A, Exp. Date February 2028, 19261225A, 19261185A, Exp. Date March 2028, 19261664A, 19261682A, Exp. Date April 2028.
- UPC codes
- 68462-626, 68462-626-52
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
July 23, 2026
Reported by FDA DRUG
August 5, 2026
RecallRadar source check
August 12, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Glenmark Pharmaceuticals Inc., USA or your healthcare provider for guidance. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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Full Description
Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ 07407, NDC 68462-626-52.. Generic: AZELAIC ACID; Brand: AZELAIC ACID. Reason: CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.. Classification: Class II. Quantity: N/A. Distribution: Nationwide within the United States.
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Safety Guide
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