FDAFDA · Food and drugs·Recall number D-0803-2026
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
Published September 2, 2026 · Recall initiated: August 6, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of particulate matter: glass and stopper piece
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ACTHAR
- Manufacturer
- Mallinckrodt Hospital Products Inc.
- Distributor
- USA Nationwide
- UPC
- 0363004871213
- Lot
- Lot#: NDC 63004-8710-1 - 1564-107, exp 1/31/2027 NDC 63004-8710-2 - 1564-107H, exp 1/31/2027
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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