Mallinckrodt Hospital Products Inc. Acthar Gel Recall
Announced 2026-09-02 · FDA
Mallinckrodt Hospital Products Inc. recalled Acthar Gel (repository corticotropin injection), 5 mL multi-dose vials (Rx Only), distributed nationwide in the USA. The recall is due to the presence of particulate matter consisting of glass and stopper pieces in some vials. The affected lots are NDC 63004-8710-1 with lot 1564-107 and NDC 63004-8710-2 with lot 1564-107H, both expiring 1/31/2027.
| Brand | Mallinckrodt Hospital Products Inc. |
|---|---|
| Product | 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 |
| Reason | Presence of particulate matter: glass and stopper piece |
| Severity | moderate |
| Units affected | 12367 |
| Distribution | USA Nationwide |
| Agency | FDA |
| Recall / campaign no. | Lot#: NDC 63004-8710-1 - 1564-107, exp 1/31/2027 NDC 63004-8710-2 - 1564-107H, exp 1/31/2027 |
WHAT YOU SHOULD DO
- Do not use Acthar Gel vials from the affected lots (63004-8710-1 with lot 1564-107 and 63004-8710-2 with lot 1564-107H) or with expiration date 1/31/2027.
- Contact your healthcare provider or pharmacist for guidance on replacement or return of the recalled product.
- Return or dispose of the affected product according to the instructions from your retailer, pharmacy, or Mallinckrodt.
- For more information, visit the FDA recall page or Mallinckrodt recall communications.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.