Quick Facts at a Glance
- Recall Date
- September 17, 2025
- Hazard Level
- HIGH
- Brands
- Glenmark Pharmaceuticals, AZELAIC ACID
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers, Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PETS
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
- Glenmark Pharmaceuticals, AZELAIC ACID
- Product type
- Azelaic Acid Gel
- Model numbers
- Batch # 19252524, Exp Date: May 2027
- UPC codes
- 68462-626, 68462-626-52
- Sizes
- 50 grams
- Sold at
- Multiple Retailers, Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 17, 2025
Reported by FDA DRUG
October 1, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
CGMP Deviations: Market complaints received for gritty texture (grainy)
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: Letter
About This Product
Azelaic acid gel is a topical treatment used for various dermatologic conditions. It is Rx-only in the U.S. and distributed nationwide.
Why This Is Dangerous
Gritty texture indicates CGMP deviations possibly affecting product quality and safety of application.
Industry Context
This recall is not part of a broader industry pattern, based on provided notice.
Real-World Impact
Consumers may experience quality concerns or irritation due to altered texture; no injuries reported in the notice.
Practical Guidance
How to identify if yours is affected
- Check NDC 68462-626-52 on the packaging.
- Check Batch #19252524 and Exp May 2027.
- Confirm product is a 50 g tube labeled Rx only.
Where to find product info
Recall letter from Glenmark and FDA enforcement page D-0662-2025.
What timeline to expect
Refunds/replacements typically processed within 4-8 weeks after submission.
If the manufacturer is unresponsive
- Document your correspondence
- Escalate to FDA consumer complaint if needed
How to prevent similar issues
- Verify CGMP compliance updates from manufacturers
- Ask for batch-specific documentation when purchasing Rx drugs
- Monitor recalls on FDA and company websites
Documentation advice
Keep recall letter, batch numbers, expiration date, and receipts as records.
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Product Details
Brand: Glenmark Pharmaceuticals. Product: Azelaic Acid Gel, 15%, 50 g. NDC: 68462-626-52. Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. Batch: 19252524. Expiration: May 2027. Sold as Rx only. Quantity: 13,824 tubes. Distribution: Nationwide in the United States.
Reported Incidents
No injuries or incidents are detailed in the recall notice.
Key Facts
- Azelaic Acid Gel 15% 50 g
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Safety Guide
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