Acthar recalls
Acthar products have been recalled 2 times, most recently on 2 Sep 2026. The recalling company is usually Mallinckrodt Hospital Products. The most common reason is particulate matter.
Total recalls2since 2024
Last 12 months1reported
Class I00% of total
Ongoing2latest 2 Sep 2026
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 2 100%Class III 0 0%
Why acthar is recalled
Companies
Product types
By year
Ongoing acthar recalls
2 active| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Acthar Gel (repository corticotropin injection) multiple-dose vial recalledActhar | Mallinckrodt Hospital Products | Particulate Matter | Nationwide |
| Drug | CLASS II | Acthar Gel (repository corticotropin injection) recalledActhar | Mallinckrodt Hospital Products | Manufacturing (CGMP) Deviations | Nationwide |
All acthar recalls, newest first
2 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Acthar Gel (repository corticotropin injection) multiple-dose vial recalledActhar | Mallinckrodt Hospital Products | Particulate Matter | Nationwide |
| Drug | CLASS II | Acthar Gel (repository corticotropin injection) recalledActhar | Mallinckrodt Hospital Products | 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.