TemporaryFDAOngoing
Can cause harm that is usually temporary. Speak to your pharmacist or doctor — do not stop a prescribed medicine on your own.
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
Check the label for
Lot#: NDC 63004-8710-1 - 1564-107, exp 1/31/2027 NDC 63004-8710-2 - 1564-107H, exp 1/31/2027
- Why
- Presence of particulate matter: glass and stopper piece
- Distributed
- USA Nationwide
- Company
- Mallinckrodt Hospital Products Inc.
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Already ate or took it and feel unwell? Call Poison Control — 1-800-222-1222
Source: FDA record D-0803-2026 · retrieved 26 August 2026
Read the official notice