Home › Prescription medicine › Glenmark Pharmaceuticals Inc., USA — Azelaic…
Glenmark Pharmaceuticals Inc., USA — Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only
Do not stop taking this without speaking to your pharmacist or doctor.
What’s wrong
CGMP Deviations: Market complaints received for gritty texture (grainy)
The Recall Registry rates this serious — FDA Class II: temporary or medically reversible health harm.
What to do
Check the lot numbers below against what you have. Do not stop taking a prescription medicine because of a recall without speaking to your pharmacist or doctor first — for many medicines stopping is more harmful than continuing, and they can tell you whether yours is affected and what to do about it.
Who to contact: Recalling firm: Glenmark Pharmaceuticals Inc., USA
The 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
Details
- Units affected
- 13824 tubes
- Recall date
- September 17, 2025
- Brand
- Glenmark Pharmaceuticals Inc., USA
Nationwide within the United States
The official notice
This recall was issued by the U.S. Food and Drug Administration. The Recall Registry summarises it — always confirm the details at the source.
Their exact wording: “Glenmark Pharmaceuticals Inc., USA — 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,”
Worried about the other things in your house? You can write down what you have and be told if one is recalled — or, if you sell second-hand, check your whole stock at once.
Filed under: Prescription medicine