{"recall":{"id":"fda-drug-99523","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Regeneron Pharmaceuticals Inc recalls Libtayo (cemiplimab-rwlc) Injection","firm":"Regeneron Pharmaceuticals Inc","date":"2026-07-28","reported":"2026-08-26","status":"Ongoing","classification":"Class II","products":[{"name":"Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), For Intravenous Infusion After Dilution, Single-Dose Vial, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., Tarrytown, NY 10591; Marketed by: Regeneron Pharmaceuticals, Inc. (Tarrytown, NY 10591), NDC 61755-008-01","code":"Lot: 8494000002, Exp 7/31/28","quantity":"21,353 vials","number":"D-0767-2026","classification":"Class II"}],"reason":"Lack of Assurance of Sterility","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"USA Nationwide","nationwide":true,"states":[],"units":"21,353 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=99523","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"b3856321758f93a4","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=99523","record":[{"status":"Ongoing","city":"Tarrytown","state":"NY","country":"United States","classification":"Class II","openfda":{"application_number":["BLA761097"],"brand_name":["LIBTAYO"],"generic_name":["CEMIPLIMAB-RWLC"],"manufacturer_name":["Regeneron Pharmaceuticals, Inc."],"product_ndc":["61755-008"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["INTRAVENOUS"],"substance_name":["CEMIPLIMAB"],"rxcui":["2058830","2058835"],"spl_id":["024fbfcd-06aa-44d2-ae90-1aa59f65425c"],"spl_set_id":["4347ae1f-d397-4f18-8b70-03897e1c054a"],"package_ndc":["61755-008-01","8494000002"],"is_original_packager":[true],"unii":["6QVL057INT"]},"product_type":"Drugs","event_id":"99523","recalling_firm":"Regeneron Pharmaceuticals Inc","address_1":"777 Old Saw Mill River Rd","address_2":"","postal_code":"10591-6717","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"USA Nationwide","recall_number":"D-0767-2026","product_description":"Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), For Intravenous Infusion After Dilution, Single-Dose Vial, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., Tarrytown, NY 10591; Marketed by: Regeneron Pharmaceuticals, Inc. (Tarrytown, NY 10591),  NDC 61755-008-01","product_quantity":"21,353 vials","reason_for_recall":"Lack of Assurance of Sterility","recall_initiation_date":"20260728","center_classification_date":"20260814","report_date":"20260826","code_info":"Lot: 8494000002, Exp 7/31/28","more_code_info":""}]}}