FDA Drug recall D-0803-2026
Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, N…
- FDA Drug
- Class II
- ongoing
- Published 2026-09-02
On 2026-09-02 the FDA classified a Class II recall of Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, N… by Mallinckrodt Hospital Products, citing presence of particulate matter: glass and stopper piece.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0803-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-06 |
| Published | 2026-09-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Mallinckrodt Hospital Products |
| Distribution | US |
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
Identifiers
| ndc | 63004-8710-1 |
|---|---|
| ndc | 63004-8710-2 |
| ndc | 63004-8712-1 |
| ndc | 63004-8712-4 |
| ndc | 63004-8711-1 |
| ndc | 63004-8711-4 |
| code_info | Lot#: NDC 63004-8710-1 - 1564-107, exp 1/31/2027 NDC 63004-8710-2 - 1564-107H, exp 1/31/2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0803-2026%22
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