{"recall":{"id":"fda-drug-99552","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Novartis Pharmaceuticals Corporation recalls Diovan (valsartan) 160 mg","firm":"Novartis Pharmaceuticals Corporation","date":"2026-08-04","reported":"2026-08-19","status":"Ongoing","classification":"Class II","products":[{"name":"Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834, Distributed by: Novartis Pharmaceutical Corp, East Hanover, NJ 07936, NDC 0078-0359-34","code":"Lot AV5913C, Expiry: 6/2027","quantity":"","number":"D-0746-2026","classification":"Class II"}],"reason":"Failed Dissolution Specifications","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide","nationwide":true,"states":[],"units":"","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=99552","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"fc9c6d5a55d705eb","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=99552","record":[{"status":"Ongoing","city":"East Hanover","state":"NJ","country":"United States","classification":"Class II","openfda":{"application_number":["NDA021283"],"brand_name":["DIOVAN"],"generic_name":["VALSARTAN"],"manufacturer_name":["Novartis Pharmaceuticals Corporation"],"product_ndc":["0078-0358","0078-0423","0078-1245","0078-0359","0078-1252","0078-0360","0078-1259"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"substance_name":["VALSARTAN"],"rxcui":["349199","349200","349201","349483","351761","351762","352001","352274"],"spl_id":["8b57e357-5cfb-49a6-a600-59ce118fd1e9"],"spl_set_id":["5ddba454-f3e6-43c2-a7a6-58365d297213"],"package_ndc":["0078-0423-15","0078-0358-34","0078-1245-34","0078-0359-34","0078-1252-34","0078-0360-34","0078-1259-34"],"is_original_packager":[true],"nui":["N0000000070","N0000175561"],"pharm_class_moa":["Angiotensin 2 Receptor Antagonists [MoA]"],"pharm_class_epc":["Angiotensin 2 Receptor Blocker [EPC]"],"unii":["80M03YXJ7I"]},"product_type":"Drugs","event_id":"99552","recalling_firm":"Novartis Pharmaceuticals Corporation","address_1":"1 Health Plz","address_2":"","postal_code":"07936-1016","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide","recall_number":"D-0746-2026","product_description":"Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834, Distributed by: Novartis Pharmaceutical Corp, East Hanover, NJ 07936, NDC 0078-0359-34","product_quantity":"","reason_for_recall":"Failed Dissolution Specifications","recall_initiation_date":"20260804","center_classification_date":"20260807","report_date":"20260819","code_info":"Lot AV5913C, Expiry: 6/2027","more_code_info":""}]}}