Mallinckrodt Hospital Products Inc. initiated a recall of Acthar Gel (repository corticotropin injection) on August 6, 2026. The recall covers the 5 mL multiple-dose vial, Rx Only product, NDC 63004-8710-1 and NDC 63004-8710-2, manufactured for Mallinckrodt ARD LLC of Bridgewater, NJ.
The FDA has classified this action as a Class II recall. The stated reason is the presence of particulate matter, specifically glass and stopper piece material, found within affected vials.
The recall status is listed as ongoing as of the reported date. This action was initiated by the recalling firm and reported through FDA recall channels.
This brief reports only the details provided in the recall record: the classification, the reason given, the firm involved, and the initiation date. No additional information about patient outcomes, distribution scope, or corrective actions has been provided in this record.
Readers seeking general information about corticotropin, including its approved uses and regulatory status, can consult the compound overview for further context.