CLASS II ONGOING Drug recall · Reported 7 Aug 2024 · FDA Enforcement Report
Glenmark, Azelaic Acid Gel, 15 % recalled by Glenmark Pharmaceuticals
Glenmark Pharmaceuticals Inc., U is recalling Glenmark, Azelaic Acid Gel, 15 %, distributed nationwide in the US. The recall was initiated on 22 Jul 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0621-2024
- FDA event ID
- 95022
- Recalling firm
- Glenmark Pharmaceuticals Inc., U, Mahwah, NJ
- Brand
- Azelaic Acid
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Jul 2024
- FDA classified
- 29 Jul 2024
- Reported
- 7 Aug 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Creams, Ointments & Gels
Timeline
| 22 Jul 2024 | Recall initiated by company | |
| 29 Jul 2024 | Classified by FDA | +7 days |
| 7 Aug 2024 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations
Product as listed by the FDA
Glenmark, Azelaic Acid Gel, 15 %, 50 grams, 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.
Where it was distributed
U.S. Nationwide
Questions about this recall
Is Glenmark, Azelaic Acid Gel, 15 % recalled?
Yes. Glenmark Pharmaceuticals Inc., U recalled Glenmark, Azelaic Acid Gel, 15 % on 22 Jul 2024. The recall is Class II and its status is Ongoing. Recall number D-0621-2024.
Why was it recalled?
CGMP Deviations
Which lots are affected?
Lot# 19241453; Exp MARCH 2026
Where was it sold?
U.S. Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Glenmark Pharmaceuticals Inc., U
All 141| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Azelaic Acid Gel, 15% tubes, For Topical Use only recalledAzelaic Acid | Glenmark Pharmaceuticals Inc., U | Foreign Material | Nationwide |
| Drug | CLASS II | Alyacen 7/7/7, Norethindrone recalled by Glenmark PharmaceuticalsAlyacen 1/35 | Glenmark Pharmaceuticals Inc., U | Potency & Assay | Nationwide |
| Drug | CLASS II | Ondansetron Orally Disintegrating Tablets, USP, 4mg recalledOndansetron | Glenmark Pharmaceuticals Inc., U | Packaging Defects | Nationwide |
| Drug | CLASS III | Nebivolol Tablets, 20 mg recalled by Glenmark PharmaceuticalsNebivolol | Glenmark Pharmaceuticals Inc., U | Other | Nationwide |
| Drug | CLASS III | Bisoprolol Fumarate and Hydrochlorothiazide Tablets recalledBisoprolol Fumarate And Hydrochlorothiazide | Glenmark Pharmaceuticals Inc., U | Packaging Defects | Nationwide |
Other Azelaic Acid recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Azelaic Acid Gel, 15% tubes, For Topical Use only recalledAzelaic Acid | Glenmark Pharmaceuticals Inc., U | Foreign Material | Nationwide |
| Drug | CLASS II | Azelaic Acid Gel, 15%, For Topical Use Only recalledAzelaic Acid | Glenmark Pharmaceuticals Inc., U | Manufacturing (CGMP) Deviations | Nationwide |