Class II

Drug 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 63004-8710-2

Mallinckrodt Hospital Products Inc. · August 6, 2026

Reason for Recall

Presence of particulate matter: glass and stopper piece

Distribution

USA Nationwide

States Affected

NATIONWIDE

Quantity Affected

12367 vials

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0803-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Mallinckrodt Hospital Products Inc. Drug 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 63004-8710-2 | SafeCheck