FDA recall, , Moderate risk
Acthar Gel (Repository Corticotropin Injection)
Acthar Gel contains particulate matter, glass and stopper piece.
Summary by Recall Canary from the FDA notice
What happened
Mallinckrodt Hospital Products Inc., of Bridgewater, New Jersey, began a recall on August 6, 2026, of Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, because the product contains particulate matter, specifically glass and stopper piece. The recall covers 12,367 vials distributed nationwide in the USA, and was added to the FDA's Enforcement Report on August 26, 2026, and classified by the FDA that same day.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Acthar Gel (repository corticotropin injection)
- NDC
- 63004-8710-1
- 63004-8710-2
- Lot code
- 1564-107
Recall details
- Company began the recall
- Sold in
USA Nationwide
- Company
- Mallinckrodt Hospital Products Inc.Bridgewater, New Jersey
- Hazard
- Foreign object
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99570
- Recall number
- D-0803-2026
- Quantity recalled
- 12367 vials
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
