Acthar Gel — Class II drug recall D-0803-2026
Ongoing recall by Mallinckrodt Hospital Products Inc., reported 2026-09-02, distributed nationwide. Presence of particulate matter: glass and stopper piece
| Recall number | D-0803-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mallinckrodt Hospital Products Inc., Bridgewater, NJ, United States |
| Recall initiated | 2026-08-06 |
| Classified | 2026-08-26 |
| Reported by FDA | 2026-09-02 |
| Distributed | Nationwide (US) |
| Quantity | 12,367 vials |
| Reason classes | foreign material, specification failure |
| NDC | 63004-8710, 63004-8710-01, 63004-8710-02, 63004-8711, 63004-8711-01, 63004-8711-04, 63004-8712, 63004-8712-01, 63004-8712-04 |
| Lot numbers | 1564-107, 1564-107H, 63004-8710-1, 63004-8710-2 |
| Expiration dates | 2027-01-31 |
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 for recall
Presence of particulate matter: glass and stopper piece
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0803-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.