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Life sciences · Safety recall
U.S. Food and Drug Administration · September 2, 2026
An action by a regulator. Authoritative on labelling and availability.
The FDA issued a Class II recall of Acthar Gel (repository corticotropin injection) 5 mL multiple-dose vials manufactured by Mallinckrodt ARD LLC due to detection of particulate matter (glass and stopper fragments) in affected lots. This recall affects all U.S. distribution and was initiated voluntarily by the firm. The source does not contain clinical trial data, efficacy information, or evidence of adverse clinical outcomes.
Safety recall. Patients prescribed Acthar Gel (repository corticotropin injection) in the United States receiving affected lots.. Intervention: Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial. USA Nationwide.
Class II recall initiated for Acthar Gel 5 mL multiple-dose vials (NDC 63004-8710-1 and NDC 63004-8710-2) Reason: Presence of particulate matter (glass and stopper piece) Distribution: Nationwide USA
This record does not contain clinical trial results, efficacy data, or documented adverse clinical outcomes. No information is provided on whether adverse events were reported or the extent of distribution prior to recall initiation.
Clinicians should be aware that affected Acthar Gel vials may contain glass or stopper fragments, creating a risk of injury if injected. Affected prescriptions should be reviewed and patients should be directed to verify lot numbers and discontinue use if they possess recalled product.
FDA Class II recall of Acthar Gel due to presence of particulate matter (glass and stopper fragments) affecting product safety and integrity.
As stated by the source record.
Quoted from the source exactly as published.
Clinicians should be aware that affected Acthar Gel vials may contain glass or stopper fragments, creating a risk of injury if injected. Affected prescriptions should be reviewed and patients should be directed to verify lot numbers and discontinue use if they possess recalled product.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
FDA enforcement report D-0803-2026. This is a regulatory safety action, not a clinical study. Classification: Class II. Status: Ongoing. Recalling firm: Mallinckrodt Hospital Products Inc.. Initiated as: Voluntary: Firm initiated. 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 Distribution: USA Nationwide
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.