SEP 2, 2026 · SAFETY RECALL
Class II recall: Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1 & NDC
U.S. Food and Drug Administration
FDA Class II recall of Acthar Gel due to presence of particulate matter (glass and stopper fragments) affecting product safety and integrity.
Regulatory UpdateMallinckrodt Hospital Products
Reported
NDC numbers affected63004-8710-1 & 63004-8710-2
Recall classificationClass II
Distribution scopeUSA Nationwide