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

Official product recall notices and clearly labeled enforcement reference records.

Reference record — not a live warning · enforcement-reference · official-source

Presence of particulate matter: glass and stopper piece

Provider: FDA — drug enforcement reference
Source observed: 9/2/2026, 12:00:00 AM UTC
Source updated: 9/2/2026, 12:00:00 AM UTC
Location: Bridgewater, NJ, US
hazard: Presence of particulate matter: glass and stopper piece
notice: Periodic enforcement reference; not a real-time safety alert or a reliable recall-lifecycle tracker.
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
distribution: USA Nationwide
manufacturer: Mallinckrodt Hospital Products Inc.
recall number: D-0803-2026
source status: Ongoing
classification: Class II
freshness minutes: 180

Source use policy · openFDA reference data; not a real-time public alert service

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