FDA recall, , Moderate risk
Glenmark Azelaic Acid Gel
Azelaic Acid Gel, 15%, 50 gram tubes may have abnormal texture or consistency described as grainy, gritty, or sandy.
Summary by Recall Canary from the FDA notice
What happened
Glenmark Pharmaceuticals Inc., USA, of Elmwood Park, New Jersey, recalled Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, distributed nationwide within the United States. The company began the recall on July 23, 2026, after receiving product quality complaints concerning abnormal texture or consistency described as grainy, gritty, or sandy. The FDA added the recall to its Enforcement Report on July 28, 2026, and it was in the weekly enforcement report on August 5, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is your tube affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Azelaic Acid Gel, 15%, 50 gram tubes
- NDC
- 68462-626-52
- Lot code
- 19260937A
Recall details
- Company began the recall
- Sold in
Nationwide within the United States.
- Company
- Glenmark Pharmaceuticals Inc., USAElmwood Park, New Jersey
- Hazard
- Manufacturing problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99490
- Recall number
- D-0731-2026
All recalls from Glenmark Pharmaceuticals Inc., USA
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
