FDA Drug · D-0803-2026

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

Class II · Ongoing

Presence of particulate matter: glass and stopper piece

Affected lots / codes — check yours against thisLot#: NDC 63004-8710-1 - 1564-107, exp 1/31/2027 NDC 63004-8710-2 - 1564-107H, exp 1/31/2027

Recalling firm: Mallinckrodt Hospital Products Inc., Bridgewater, NJ
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 12367 vials
Distribution: USA Nationwide
Recall initiated: August 6, 2026
Classified: August 26, 2026
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0803-2026%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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