Recall: D-0803-2026

Class II - Potentially Harmful

Class IIClassification

2026-08-06Initiated

OngoingStatus

Mallinckrodt Hospital ProductsFirm

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

Presence of particulate matter: glass and stopper piece

Distribution

USA Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.