Azelaic Acid Gel recall
FDA recall D-0662-2025 · initiated Sep 17, 2025
Glenmark Pharmaceuticals Inc., USA recalled Azelaic Acid Gel in Sep 2025 — an FDA Class II recall (D-0662-2025) because CGMP Deviations: Market complaints received for gritty texture (grainy).
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations: Market complaints received for gritty texture (grainy)
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: 13824 tubes
Details
- Product
- Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-626-52
- Recalling company
- Glenmark Pharms
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States
- Initiated
- Sep 17, 2025
- FDA report date
- Oct 1, 2025
Frequently asked
- Was Azelaic Acid Gel recalled?
- Glenmark Pharmaceuticals Inc., USA recalled Azelaic Acid Gel in Sep 2025 — an FDA Class II recall (D-0662-2025) because CGMP Deviations: Market complaints received for gritty texture (grainy). 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-0662-2025 was: CGMP Deviations: Market complaints received for gritty texture (grainy)
- 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 — Batch # 19252524, Exp Date: May 2027. 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-0662-2025.