Latest recalls
FDAClass IISeptember 2, 2026

Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC…

Why it was recalled

Presence of particulate matter: glass and stopper piece

What to do

The recall is ongoing. Follow the firm and FDA instructions.

Affected products and identifiers

Lot#: NDC 63004-8710-1 - 1564-107, exp 1/31/2027 NDC 63004-8710-2 - 1564-107H, exp 1/31/2027 — 12367 vials

Record details

Mallinckrodt Hospital Products Inc. — USA Nationwide

Open FDA enforcement record