{"recall":{"id":"fda-drug-99806","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Inventia Healthcare Limited recalls Chlorthalidone Tablets","firm":"Inventia Healthcare Limited","date":"2026-09-03","reported":"2026-09-23","status":"Ongoing","classification":"Class II","products":[{"name":"Chlorthalidone Tablets, USP, 25 mg, 100 Tablets per bottle, Rx only, Manufactured by: Inventia Healthcare Limited. NDC: 64980-599-01","code":"Batch # RISA24002; Exp Date: 04/2027","quantity":"13567 bottles","number":"D-0852-2026","classification":"Class II"}],"reason":"Failed Dissolution Specifications","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"U.S. Nationwide","nationwide":true,"states":[],"units":"13567 bottles","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=99806","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"05b0f6f64a6d3411","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=99806","record":[{"status":"Ongoing","city":"Kalyan","state":"N/A","country":"India","classification":"Class II","openfda":{"application_number":["ANDA211320"],"brand_name":["CHLORTHALIDONE"],"generic_name":["CHLORTHALIDONE"],"manufacturer_name":["Rising Pharma Holdings, Inc."],"product_ndc":["64980-599","64980-600"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"substance_name":["CHLORTHALIDONE"],"rxcui":["197499","197500"],"spl_id":["6404aaa7-05c8-4f96-a091-3f07248ffbd5"],"spl_set_id":["71b1d074-0521-4cd1-beb5-fedd61f52eca"],"package_ndc":["64980-599-01","64980-599-10","64980-600-01"],"is_original_packager":[true],"upc":["0364980599108","0364980599016","0364980600019"],"nui":["N0000175359","N0000175420"],"pharm_class_pe":["Increased Diuresis [PE]"],"pharm_class_epc":["Thiazide-like Diuretic [EPC]"],"unii":["Q0MQD1073Q"]},"product_type":"Drugs","event_id":"99806","recalling_firm":"Inventia Healthcare Limited","address_1":"Additional Ambernath Midc","address_2":"Ambernath East; F1-F1/1-F75/1","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"U.S. Nationwide","recall_number":"D-0852-2026","product_description":"Chlorthalidone Tablets, USP, 25 mg, 100 Tablets per bottle, Rx only, Manufactured by: Inventia Healthcare Limited.   NDC:  64980-599-01","product_quantity":"13567 bottles","reason_for_recall":"Failed Dissolution Specifications","recall_initiation_date":"20260903","center_classification_date":"20260917","report_date":"20260923","code_info":"Batch # RISA24002; Exp Date: 04/2027","more_code_info":""}]}}