OVERLOOKED

Recalls › Medicines & devices

Class IIOngoing

Mallinckrodt Hospital Products Inc. recalls Acthar Gel (repository corticotropin injection)

Recall date · record updated Sep 2, 2026 · Source: U.S. Food and Drug Administration (openFDA drug enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Mallinckrodt Hospital Products Inc.
Reason
Presence of particulate matter: glass and stopper piece
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
USA Nationwide
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99570…

Products

  1. 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

    Codes/lots: Lot#: NDC 63004-8710-1 - 1564-107, exp 1/31/2027 NDC 63004-8710-2 - 1564-107H, exp 1/31/2027Quantity: 12367 vialsRecall no. D-0803-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

More Medicines & devices recalls