Mallinckrodt Acthar Gel 5mL Vial Recall: Particulate Matter Hazard
Mallinckrodt recalls Acthar Gel 5mL vials due to glass and stopper particles. Patients should contact their doctor for alternative treatment options.
Stop using this now
Presence of particulate matter: glass and stopper piece
What happened, in plain English
Mallinckrodt is recalling Acthar Gel 5mL multiple-dose vials because they may contain glass and stopper particles. This could cause serious injury if injected. Patients should not use these vials and contact their doctor for alternatives. Read more at govinfonow.com/recall/692859-mallinckrodt-acthar-gel-5ml-vial-recall-particulate-matter-hazard.
Source Summary by GovInfoNow · govinfonow.com/recall/692859-mallinckrodt-acthar-gel-5ml-vial-recall-particulate-matter-hazard · Updated September 14, 2026 · FDA enforcement record: FDA #D-0803-2026
Cite this page
“Mallinckrodt Acthar Gel 5mL Vial Recall: Particulate Matter Hazard.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/692859-mallinckrodt-acthar-gel-5ml-vial-recall-particulate-matter-hazard. Based on FDA recall #D-0803-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0803-2026%22&limit=1).
Why it’s dangerous
The vials may contain glass and stopper fragments that can be injected into the body. This could cause serious injury, including tissue damage or infection.
Who’s affected
Patients prescribed Acthar Gel injections for conditions like multiple sclerosis. Those using the recalled vials are at risk of serious injury from injected particles.
How to tell if you have this one
Check for vials labeled 'Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only' with NDC 63004-8710-1 or 63004-8710-2. These were manufactured by Mallinckrodt ARD LLC in Bridgewater, NJ.
- Brand
Mallinckrodt- Category
Drug
What to do — step by step
Stop Using Vial Now
Immediately stop using the recalled Acthar Gel vials as they may contain glass and stopper particles that can cause serious injury.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “USA Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 27 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest drug recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0803-2026 (August 6, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0803-2026 to see it in context.
- Plain-language summary written by qwen3:4b on September 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.