Drug recall
Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only, Mfd. for: Mallinckrodt ARD…
FDA recall event 99570 · Class II · Mallinckrodt Hospital Products Inc.
Key facts
| Event ID | 99570 |
|---|---|
| Recall numbers | D-0803-2026 |
| Recalling firm | Mallinckrodt Hospital Products Inc. |
| Product type | Drugs |
| Products | 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 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Presence of particulate matter: glass and stopper piece |
| Initiation date | Aug 6, 2026 |
| Report date | Sep 2, 2026 |
| City | Bridgewater |
| State | NJ |
| Country | United States |
| FEI number | 3014074925 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: