Class IIDrugOngoing

Mallinckrodt Hospital Products Inc.

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

Reason for recall

Presence of particulate matter: glass and stopper piece

Details

Recall number: D-0803-2026
Event ID: 99570
Recall initiated: Aug 6, 2026
Classified: Aug 26, 2026
Reported: Sep 2, 2026
Quantity: 12367 vials
Distribution: USA Nationwide
Initiated by: Voluntary: Firm initiated
Firm notification: Letter
Firm location: Bridgewater, NJ, United States
Lot / code info: Lot#: NDC 63004-8710-1 - 1564-107, exp 1/31/2027 NDC 63004-8710-2 - 1564-107H, exp 1/31/2027