Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Acthar Gel (repository corticotropin injection) 400 USP units/5mL (80 USP Recalled by Mallinckrodt Hospital Products Inc. Due to cGMP deviations: Temperature excursion due to shipping delay...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Mallinckrodt Hospital Products Inc. directly.
Affected Products
Acthar Gel (repository corticotropin injection) 400 USP units/5mL (80 USP units/mL), 5mL multiple-dose vial, Rx only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1
Quantity: 8 vials involved in recall (16,479 vials distributed)
Why Was This Recalled?
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Mallinckrodt Hospital Products Inc.
Mallinckrodt Hospital Products Inc. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report