FDARecall 99490Medicines
What to do
The FDA record of this recall has no instruction for consumers. Compare the lot codes below with your product. If they match, do not use it, and follow the notice of the firm or ask the store where you bought it. Talk to your pharmacist or doctor before stopping a medicine.Note from Recalls Watch, not agency text.
Read the official notice on accessdata.fda.gov (opens in a new tab)
Hazard
Why it was recalled
CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
FDA classification: Class II. Use may cause temporary or medically reversible health consequences, or the chance of serious consequences is remote. Status: Ongoing.
Is it yours? Products and codes
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.
- Lot or code
- Lot #: 19260937A, Exp. Date February 2028; 19261225A, 19261185A, Exp. Date March 2028; 19261664A, 19261682A, Exp. Date April 2028.
- FDA recall number
- D-0731-2026
Distribution (FDA): Nationwide within the United States.
About this record
- Issued by
- U.S. Food and Drug Administration
- Firm
- Glenmark Pharmaceuticals Inc., USA
- Title
- Composed by Recalls Watch from fields of the record; FDA records have no title.