Mallinckrodt Hospital Products Inc. Acthar Gel Recall
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 |
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.
How to identify the recalled item
| Lot / date codes | Lot#: NDC 63004-8710-1 - 1564-107, exp 1/31/2027 NDC 63004-8710-2 - 1564-107H, exp 1/31/2027 |
|---|---|
| Lot / date codes | Lot#: NDC 63004-8710-1 - 1564-107, exp 1/31/2027 NDC 63004-8710-2 - 1564-107H, exp 1/31/2027 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
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.