{"recall":{"id":"fda-drug-99657","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Sage Products, LLC recalls 2% Chlorhexidine Gluconate* Cloth","firm":"Sage Products, LLC","date":"2026-08-18","reported":"2026-09-09","status":"Ongoing","classification":"Class II","products":[{"name":"2% Chlorhexidine Gluconate* Cloth, Non-sterile, 6 Disposable cloths, Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013. NDC: 53462-705-26","code":"Lot 108491 with case sequence numbers 14841 through 20013.","quantity":"165,536 packages","number":"D-0837-2026","classification":"Class II"}],"reason":"Cross Contamination with Other Products","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide.","nationwide":true,"states":[],"units":"165,536 packages","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=99657","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"e43b65d9e7e330fe","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=99657","record":[{"status":"Ongoing","city":"Cary","state":"IL","country":"United States","classification":"Class II","openfda":{"application_number":["NDA021669"],"brand_name":["CHLORHEXIDINE GLUCONATE"],"generic_name":["CHLORHEXIDINE GLUCONATE"],"manufacturer_name":["Sage Products LLC"],"product_ndc":["53462-705"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"substance_name":["CHLORHEXIDINE GLUCONATE"],"rxcui":["846127"],"spl_id":["54620ea3-da65-c5d7-e063-6394a90ad14a"],"spl_set_id":["bdb6a012-37e5-4664-84a3-134bea284744"],"package_ndc":["53462-705-20","53462-705-23","53462-705-26"],"is_original_packager":[true],"upc":["0618029850607"],"unii":["MOR84MUD8E"]},"product_type":"Drugs","event_id":"99657","recalling_firm":"Sage Products, LLC","address_1":"3909 3 Oaks Rd","address_2":"N/A","postal_code":"60013-1804","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide.","recall_number":"D-0837-2026","product_description":"2% Chlorhexidine Gluconate* Cloth, Non-sterile, 6 Disposable cloths, Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013.  NDC: 53462-705-26","product_quantity":"165,536 packages","reason_for_recall":"Cross Contamination with Other Products","recall_initiation_date":"20260818","center_classification_date":"20260911","report_date":"20260909","code_info":"Lot 108491 with case sequence numbers 14841 through 20013.","more_code_info":""}]}}