{"recall":{"id":"fda-drug-99670","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"American Regent, Inc. recalls Epinephrine Injection","firm":"American Regent, Inc.","date":"2026-08-11","reported":"2026-09-16","status":"Ongoing","classification":"Class I","products":[{"name":"Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx Only, For Intravenous Infusion, intramuscular and Subcutaneous Use, AMERICAN REGENT INC., SHIRLEY, NY 11967. NDC 0517-3030-01","code":"Lots: 25128L1C0, Exp. August 31, 2026; 25280L1C0, Exp. October 31, 2026; 26108L1C0, Exp. July 31, 2027","quantity":"31,935 30mL-vials","number":"D-0865-2026","classification":"Class I"}],"reason":"Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials.","hazard":"FDA Class I: a reasonable probability that use or exposure will cause serious adverse health consequences or death (FDA definition).","affected":"Nationwide within the U.S.A","nationwide":true,"states":[],"units":"31,935 30mL-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=99670","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"fe023117cfb859c3","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=99670","record":[{"status":"Ongoing","city":"Shirley","state":"NY","country":"United States","classification":"Class I","openfda":{"application_number":["ANDA217192"],"brand_name":["EPINEPHRINE"],"generic_name":["EPINEPHRINE"],"manufacturer_name":["American Regent, Inc."],"product_ndc":["0517-3030"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["INTRAMUSCULAR","INTRAVENOUS","SUBCUTANEOUS"],"substance_name":["EPINEPHRINE"],"rxcui":["310132"],"spl_id":["495f1aad-cf64-41ab-9f9e-59f6ebeb44aa"],"spl_set_id":["61cacda5-64ee-45ca-b94c-e8640c43e581"],"package_ndc":["0517-3030-01"],"is_original_packager":[true],"nui":["N0000000209","N0000000245","N0000175552","N0000175555","N0000175570","M0003647"],"pharm_class_moa":["Adrenergic alpha-Agonists [MoA]","Adrenergic beta-Agonists [MoA]"],"pharm_class_epc":["alpha-Adrenergic Agonist [EPC]","beta-Adrenergic Agonist [EPC]","Catecholamine [EPC]"],"pharm_class_cs":["Catecholamines [CS]"],"unii":["YKH834O4BH"]},"product_type":"Drugs","event_id":"99670","recalling_firm":"American Regent, Inc.","address_1":"5 Ramsay Rd","address_2":"","postal_code":"11967-4701","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Nationwide within the U.S.A","recall_number":"D-0865-2026","product_description":"Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx Only, For Intravenous Infusion, intramuscular and Subcutaneous Use, AMERICAN REGENT INC., SHIRLEY, NY 11967. NDC 0517-3030-01","product_quantity":"31,935 30mL-vials","reason_for_recall":"Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials.","recall_initiation_date":"20260811","center_classification_date":"20260922","report_date":"20260916","code_info":"Lots: 25128L1C0, Exp. August 31, 2026; 25280L1C0, Exp. October 31, 2026; 26108L1C0, Exp. July 31, 2027","more_code_info":""}]}}