{"recall":{"id":"fda-drug-99603","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Fresenius Kabi USA, LLC recalls Tyenne (tocilizumab-aazg) Injection","firm":"Fresenius Kabi USA, LLC","date":"2026-08-10","reported":"2026-09-02","status":"Ongoing","classification":"Class I","products":[{"name":"Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by Fresenius Kabi USA, LLC, Lake Zurich, Illinois, 60047, NDC 65219-594-20.","code":"Lot: 16UI07, Exp 08/31/2028","quantity":"4,643 20mL-vials","number":"D-0827-2026","classification":"Class I"}],"reason":"Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.","hazard":"FDA Class I: a reasonable probability that use or exposure will cause serious adverse health consequences or death (FDA definition).","affected":"Nationwide in the USA","nationwide":true,"states":[],"units":"4,643 20mL-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=99603","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"fb4d4a5f6a5015e5","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=99603","record":[{"status":"Ongoing","city":"Lake Zurich","state":"IL","country":"United States","classification":"Class I","openfda":{"application_number":["BLA761275"],"brand_name":["TYENNE"],"generic_name":["TOCILIZUMAB-AAZG"],"manufacturer_name":["Fresenius Kabi USA, LLC"],"product_ndc":["65219-590","65219-592","65219-594"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["INTRAVENOUS"],"substance_name":["TOCILIZUMAB"],"rxcui":["2679431","2679438","2679440","2679441","2679442","2679443"],"spl_id":["363d125e-6d69-4bb2-ae09-5eeb5d9edbae"],"spl_set_id":["e400bbe6-43c5-4de6-82b9-cb44ce3cd906"],"package_ndc":["65219-590-04","65219-592-10","65219-594-20"],"is_original_packager":[true],"nui":["N0000190478","N0000190480"],"pharm_class_moa":["Interleukin 6 Receptor Antagonists [MoA]"],"pharm_class_epc":["Interleukin-6 Receptor Antagonist [EPC]"],"unii":["I031V2H011"]},"product_type":"Drugs","event_id":"99603","recalling_firm":"Fresenius Kabi USA, LLC","address_1":"3 Corporate Dr","address_2":"N/A","postal_code":"60047-8930","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distribution_pattern":"Nationwide in the USA","recall_number":"D-0827-2026","product_description":"Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured  by Fresenius Kabi USA, LLC,  Lake Zurich, Illinois, 60047, NDC 65219-594-20.","product_quantity":"4,643 20mL-vials","reason_for_recall":"Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.","recall_initiation_date":"20260810","center_classification_date":"20260901","report_date":"20260902","code_info":"Lot: 16UI07, Exp 08/31/2028"}]}}