Recall D-0803-2026

US Class II Ongoing · initiated 2026-08-06

Recalling firm

Mallinckrodt Hospital Products Inc., NJ

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

Reason for recall

Presence of particulate matter: glass and stopper piece

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