Mallinckrodt Hospital Products Inc. recalls Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only, Mfd. for: Mallinckrodt ARD LLC, Bridg
Recalled September 2, 2026 · FDA recall D-0803-2026 · Mallinckrodt Hospital Products
Hazard
Presence of particulate matter: glass and stopper piece · FDA Class II
Units
12367 vials
Sold at
USA Nationwide
Description
Presence of particulate matter: glass and stopper piece
Product
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
Manufacturer(s)
Mallinckrodt Hospital Products Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →