Mallinckrodt Hospital Products Inc.: Acthar Gel (repository Corticotropin Injection)
Acthar Gel Recall Summary Mallinckrodt Hospital Products Inc. is recalling Acthar Gel (a prescription injection medication) because some vials contain glass particles and pieces of the rubber stopper. The recall affects 5 mL multiple-dose vials distributed nationwide across all U.S. states and Washington, D.C. This is classified as a Class II recall, meaning use of the affected product could cause serious health problems.
- Recalling firm
- 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
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-08-06
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- USA Nationwide
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/3a26845d-84ea-409a-830f-49e3f56e3e1d