Reported Sep 2, 2026 · Ongoing · Updated Sep 7, 2026
Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only, Mfd. for: Mallinckrodt ARD LLC,…
Mallinckrodt Hospital Products Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mallinckrodt Hospital Products Inc. · 440 Us Highway 22 Ste 302 · Bridgewater, NJ · 08807-2477
Is this the product you have?
- Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only, Mfd
- forMallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1 & NDC 63004-8710-2
- Lot codes and dates
Lot#: NDC 63004-8710-1 - 1564-107exp 1/31/2027 NDC 63004-8710-2 - 1564-107Hexp 1/31/2027
- Amount recalled
- 12367 vials
Where it was sold
- Nationwide
Why it was recalled
Presence of particulate matter: glass and stopper piece
This product could cause temporary or reversible health problems — stop using it.
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