FDA-Drug2026-09-02Class IIPACKAGING DEFECT
Mallinckrodt Acthar Gel injection recalled for glass and stopper particulate contamination
What this means
Mallinckrodt has recalled specific lots of Acthar Gel (repository corticotropin injection) due to the presence of glass and stopper pieces in the vials. This contamination could pose a risk if the affected medication is used. The recall affects 12,367 vials with lot numbers 1564-107 and 1564-107H, both expiring January 31, 2027.
- Check your Acthar Gel vials for lot numbers 1564-107 or 1564-107H with expiration date 1/31/2027.
- Do not use vials from these lots.
- Contact your pharmacy or healthcare provider for a replacement or alternative medication.
- Report any use of contaminated vials to the FDA MedWatch program or your healthcare provider.
The agency's original wording
Hazard
Presence of particulate matter: glass and stopper piece
Intended for
Adults
Illnesses reported
None reported
Sold states
USA Nationwide
Affected count
12367 vials
Manufactured in
440 Us Highway 22 Ste 302, N/A, Bridgewater, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0803-2026Want us to check the next one for you?
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