Azelaic Acid recalls
Azelaic Acid products have been recalled 3 times, most recently on 5 Aug 2026. The recalling company is usually Glenmark Pharmaceuticals Inc., U. The most common reason is manufacturing (cgmp) deviations.
Total recalls3since 2024
Last 12 months2reported
Class I00% of total
Ongoing3latest 5 Aug 2026
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 3 100%Class III 0 0%
Why azelaic acid is recalled
Companies
Product types
By year
Ongoing azelaic acid recalls
3 active| 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 |
| Drug | CLASS II | Glenmark, Azelaic Acid Gel, 15 % recalled by Glenmark PharmaceuticalsAzelaic Acid | Glenmark Pharmaceuticals Inc., U | Manufacturing (CGMP) Deviations | Nationwide |
All azelaic acid recalls, newest first
3 total| 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 |
| Drug | CLASS II | Glenmark, Azelaic Acid Gel, 15 % recalled by Glenmark PharmaceuticalsAzelaic Acid | Glenmark Pharmaceuticals Inc., U | Manufacturing (CGMP) Deviations | Nationwide |
About this list
Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.