{"recall":{"id":"fda-drug-99972","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"J&J INNOVATIVE MEDICINE recalls IMAAVY (nipocalimab-aahu) Injection","firm":"J&J INNOVATIVE MEDICINE","date":"2026-09-23","reported":"2026-10-14","status":"Ongoing","classification":"Class II","products":[{"name":"IMAAVY (nipocalimab-aahu) Injection, 300 mg /1.62 mL (185 mg/mL) per single-dose vial, For Intravenous Infusion After Dilution, Rx only, Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044. NDC: 57894-800-01","code":"Lot JNYJ1208; Exp. 10/30/2027","quantity":"49 vials","number":"D-0016-2027","classification":"Class II"}],"reason":"Presence of particulate matter.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"OH","nationwide":false,"states":["OH"],"units":"49 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=99972","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"6dc564e8611d03f0","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=99972","record":[{"status":"Ongoing","city":"Malvern","state":"PA","country":"United States","classification":"Class II","openfda":{"application_number":["BLA761430"],"brand_name":["IMAAVY"],"generic_name":["NIPOCALIMAB-AAHU"],"manufacturer_name":["Janssen Biotech, Inc."],"product_ndc":["57894-800","57894-801"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["INTRAVENOUS"],"substance_name":["NIPOCALIMAB"],"rxcui":["2712699","2712706","2712708","2712709"],"spl_id":["38376edc-230b-4b2b-8bb6-55b9dccea7a5"],"spl_set_id":["8886274c-f2b2-48af-85c1-2f90bfe304b8"],"package_ndc":["57894-801-01","57894-800-01"],"is_original_packager":[true],"unii":["87M90CV8NC"]},"product_type":"Drugs","event_id":"99972","recalling_firm":"J&J INNOVATIVE MEDICINE","address_1":"200 Great Valley Pkwy","address_2":"N/A","postal_code":"19355-1307","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"OH","recall_number":"D-0016-2027","product_description":"IMAAVY (nipocalimab-aahu) Injection, 300 mg /1.62 mL (185 mg/mL) per single-dose vial, For Intravenous Infusion After Dilution, Rx only, Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044.  NDC: 57894-800-01","product_quantity":"49 vials","reason_for_recall":"Presence of particulate matter.","recall_initiation_date":"20260923","center_classification_date":"20261008","report_date":"20261014","code_info":"Lot JNYJ1208; Exp. 10/30/2027"}]}}