D-0803-2026 Class II Ongoing
FDA drug recall D-0803-2026 was initiated by Mallinckrodt Hospital Products Inc. on August 6, 2026 and is designated Class II. Reason for recall: Presence of particulate matter: glass and stopper piece The recall status is ongoing. Affected quantity: 12367 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- September 2, 2026
- Initiation Date
- August 6, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12367 vials
Product Description
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
Distribution Pattern
USA Nationwide
Code Information
Lot#: NDC 63004-8710-1 - 1564-107, exp 1/31/2027 NDC 63004-8710-2 - 1564-107H, exp 1/31/2027