Acthar Gel recall (Mallinckrodt Hospital Products Inc.)
DrugClass IIOngoing
Summary: Mallinckrodt Hospital Products Inc. is recalling 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.
What is being recalled
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
Why
Presence of particulate matter: glass and stopper piece
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
USA Nationwide
How to tell if yours is affected
Lot#: NDC 63004-8710-1 - 1564-107, exp 1/31/2027 NDC 63004-8710-2 - 1564-107H, exp 1/31/2027
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0803-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | August 6, 2026 |
| Reported | September 2, 2026 |
| Company | Mallinckrodt Hospital Products Inc. |
| Company location | Bridgewater, NJ, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 12367 vials |
More recalls from Mallinckrodt Hospital Products Inc. · all drug recalls · recalls from August 2026