FDA recall D-0803-2026

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

Distribution

USA Nationwide

Key facts

Status

Ongoing

Initiation date

2026-08-06

Report date

2026-09-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bridgewater, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0803-2026