Mallinckrodt Hospital Products Inc. recalls Acthar Gel
- Recalling company
- Mallinckrodt Hospital Products Inc.
- 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
- Presence of particulate matter: glass and stopper piece
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Aug 6, 2026
- Reported
- Sep 2, 2026
- Distribution
- USA Nationwide
- Status
- Ongoing
- Quantity
- 12367 vials
- Lot / codes
- Lot#: NDC 63004-8710-1 - 1564-107, exp 1/31/2027 NDC 63004-8710-2 - 1564-107H, exp 1/31/2027
- Company location
- Bridgewater, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0803-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0803-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.