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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

Presence of particulate matter: glass and stopper piece

Class II Medicine & devices FDA September 2, 2026 Reached Texas
Read the official FDA notice →

What to do

Stop using the product and check it against the description above. Follow the remedy on the official notice; most recalls are refunded or replaced without a receipt. If you or a family member has already been affected, keep the packaging and the lot code — they're what a claim rests on later.

Details

Recalling company
Mallinckrodt Hospital Products Inc. — Bridgewater, NJ
Severity
Class II — moderate
Reported
September 2, 2026
Quantity
12367 vials
Recall number
D-0803-2026
Status
Ongoing
Source
FDA

Where it went

USA Nationwide

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