Reported Aug 5, 2026 · Ongoing · Updated Sep 16, 2026
Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharmaceuticals Inc.,…
Glenmark Pharmaceuticals Inc., USA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Glenmark Pharmaceuticals Inc., USA · 619 River Dr · Elmwood Park, NJ · 07407-1317
Is this the product you have?
- Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only
- Distributed byGlenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ 07407, NDC 68462-626-52
- Lot codes and dates
Lot #: 19260937AExp. Date February 202819261225A19261185AExp. Date March 202819261664A19261682AExp. Date April 2028
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
This product could cause temporary or reversible health problems — stop using it.
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