FDAFDA recall D-0803-2026 · Sep 2, 2026
Mallinckrodt Hospital Products Inc.: Acthar Gel (repository corticotropin injection) recall
Recall found
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
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lot#: NDC 63004-8710-1 - 1564-107, exp 1/31/2027 NDC 63004-8710-2 - 1564-107H, exp 1/31/2027
- Quantity
- 12367 vials
- Distribution
- USA Nationwide
- Recalling firm
- Mallinckrodt Hospital Products Inc., Bridgewater, NJ
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-08-06
Source: openFDA enforcement record D-0803-2026 · search recall number D-0803-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.