{"recall":{"id":"fda-drug-99570","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Mallinckrodt Hospital Products Inc. recalls Acthar Gel (repository corticotropin injection)","firm":"Mallinckrodt Hospital Products Inc.","date":"2026-08-06","reported":"2026-09-02","status":"Ongoing","classification":"Class II","products":[{"name":"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","code":"Lot#: NDC 63004-8710-1 - 1564-107, exp 1/31/2027 NDC 63004-8710-2 - 1564-107H, exp 1/31/2027","quantity":"12367 vials","number":"D-0803-2026","classification":"Class II"}],"reason":"Presence of particulate matter: glass and stopper piece","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"USA Nationwide","nationwide":true,"states":[],"units":"12367 vials","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99570","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"959e01e00ed21660","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99570","record":[{"status":"Ongoing","city":"Bridgewater","state":"NJ","country":"United States","classification":"Class II","openfda":{},"product_type":"Drugs","event_id":"99570","recalling_firm":"Mallinckrodt Hospital Products Inc.","address_1":"440 Us Highway 22 Ste 302","address_2":"N/A","postal_code":"08807-2477","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"USA Nationwide","recall_number":"D-0803-2026","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","product_quantity":"12367 vials","reason_for_recall":"Presence of particulate matter: glass and stopper piece","recall_initiation_date":"20260806","center_classification_date":"20260826","report_date":"20260902","code_info":"Lot#:  NDC 63004-8710-1 - 1564-107, exp 1/31/2027  NDC 63004-8710-2 - 1564-107H, exp 1/31/2027"}]}}