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Acthar Gel (repository corticotropin injection) recall

Mallinckrodt Hospital Products Inc. recalled Acthar Gel (repository corticotropin injection) on September 2, 2026 because of presence of particulate matter: glass and stopper piece. It was sold nationwide.

Why it was recalled

Presence of particulate matter: glass and stopper piece

What's recalled

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

Quantity: 12367 vials

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Mallinckrodt Hospital Products Inc., Bridgewater, NJ
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
USA Nationwide
Status
Ongoing
Recall number
D-0803-2026
Source
U.S. Food and Drug Administration

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