Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only, Mfd. for: Mallinckrodt ARD LLC, Bridg
Summary
The FDA issued a Class II for Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Onl by Mallinckrodt Hospital Products Inc.. Reason: Presence of particulate matter: glass and stopper piece.
Details
Source
Drug Recall
External ID
D-0803-2026
Action Date
2026-09-02
Status
Ongoing
Category
drug
Product Description
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
Lot/Code Info: Lot#: NDC 63004-8710-1 - 1564-107, exp 1/31/2027 NDC 63004-8710-2 - 1564-107H, exp 1/31/2027
Quantity Affected: 12367 vials
Reason for Recall
Presence of particulate matter: glass and stopper piece
Distribution
USA Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-06
Company
Bridgewater, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 38 drug recalls issued in the same week, part of 66 drug-related FDA actions this month.
Mallinckrodt Hospital Products Inc. has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Mallinckrodt Hospital Products Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Mallinckrodt Hospital Products Inc. have FDA actions?
Mallinckrodt Hospital Products Inc. has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0803-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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