Azelaic Acid Gel recall
FDA recall D-0731-2026 · initiated Jul 23, 2026
Glenmark Pharmaceuticals Inc., USA recalled Azelaic Acid Gel in Jul 2026 — an FDA Class II recall (D-0731-2026) because CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: N/A
Details
- Product
- 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.
- Recalling company
- Glenmark Pharms
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States.
- Initiated
- Jul 23, 2026
- FDA report date
- Aug 5, 2026
Frequently asked
- Was Azelaic Acid Gel recalled?
- Glenmark Pharmaceuticals Inc., USA recalled Azelaic Acid Gel in Jul 2026 — an FDA Class II recall (D-0731-2026) because CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Azelaic Acid Gel recalled?
- Per the FDA enforcement record, the reason for recall D-0731-2026 was: CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
- Is a recalled Azelaic Acid Gel dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Azelaic Acid Gel are affected?
- Distributed: Nationwide within the United States.. The recall covers these lots — Lot #: 19260937A, Exp. Date February 2028; 19261225A, 19261185A, Exp. Date March 2028; 19261664A, 19261682A, Exp. Date April 2028.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0731-2026.