{"recall":{"id":"fda-drug-99705","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Chiesi USA, Inc. recalls Revcovi (elapegademase-lvlr) Injection","firm":"Chiesi USA, Inc.","date":"2026-08-19","reported":"2026-09-09","status":"Ongoing","classification":"Class III","products":[{"name":"Revcovi (elapegademase-lvlr) Injection, 2.4mg/1.5mL (1.6 mg/mL), Single-Dose Vial, Rx Only, For Intramuscular Use Only, Mfd. by Chiesi USA, Inc., Cary, NC 27518, NDC 10122-502-01","code":"Lot#: 1221973, Exp 3/24/2027","quantity":"3,002 vials","number":"D-0838-2026","classification":"Class III"}],"reason":"Failed Stability Specifications: Out of specification stability result for the protein concentration profile.","hazard":"FDA Class III: not likely to cause adverse health consequences (FDA definition).","affected":"MO, TN","nationwide":false,"states":["MO","TN"],"units":"3,002 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=99705","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"e26894dccbfc9e9c","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=99705","record":[{"status":"Ongoing","city":"Cary","state":"NC","country":"United States","classification":"Class III","openfda":{"application_number":["BLA761092"],"brand_name":["REVCOVI"],"generic_name":["ELAPEGADEMASE-LVLR"],"manufacturer_name":["Chiesi USA, Inc."],"product_ndc":["10122-502"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["INTRAMUSCULAR"],"substance_name":["ELAPEGADEMASE"],"rxcui":["2059223","2059228"],"spl_id":["1b1625bb-25b0-4845-af56-5c06a0715672"],"spl_set_id":["8c073f84-cdd0-40e4-b3a9-172687267f28"],"package_ndc":["10122-502-01"],"is_original_packager":[true],"unii":["9R3D3Y0UHS"]},"product_type":"Drugs","event_id":"99705","recalling_firm":"Chiesi USA, Inc.","address_1":"175 Regency Woods Pl Ste 600","address_2":"N/A","postal_code":"27518-6007","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"MO, TN","recall_number":"D-0838-2026","product_description":"Revcovi (elapegademase-lvlr) Injection, 2.4mg/1.5mL (1.6 mg/mL), Single-Dose Vial, Rx Only, For Intramuscular Use Only, Mfd. by Chiesi USA, Inc., Cary, NC 27518,  NDC 10122-502-01","product_quantity":"3,002 vials","reason_for_recall":"Failed Stability Specifications: Out of specification stability result for the protein concentration profile.","recall_initiation_date":"20260819","center_classification_date":"20260911","report_date":"20260909","code_info":"Lot#: 1221973, Exp 3/24/2027","more_code_info":""}]}}