{"recall":{"id":"fda-drug-99893","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Ajanta Pharma USA Inc recalls Ranolazine Extended-Release Tablets","firm":"Ajanta Pharma USA Inc","date":"2026-09-17","reported":"2026-10-07","status":"Ongoing","classification":"Class II","products":[{"name":"Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807. NDC: 27241-126-02","code":"Lot: DJ25134, Exp 11/30/2028","quantity":"","number":"D-0010-2027","classification":"Class II"}],"reason":"Failed Dissolution Specifications: below specification","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Nationwide in the US.","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=99893","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"c361d4a756b20da1","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=99893","record":[{"status":"Ongoing","city":"Bridgewater","state":"NJ","country":"United States","classification":"Class II","openfda":{"application_number":["ANDA210054"],"brand_name":["RANOLAZINE"],"generic_name":["RANOLAZINE"],"manufacturer_name":["Ajanta Pharma USA Inc."],"product_ndc":["27241-125","27241-126"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"substance_name":["RANOLAZINE"],"rxcui":["616749","728231"],"spl_id":["933f695e-e4f4-4c75-80fc-aea9a30aa13d"],"spl_set_id":["8bfd1a61-547a-4847-ae4e-480b17da6272"],"package_ndc":["27241-125-02","27241-125-05","27241-126-02","27241-126-05"],"is_original_packager":[true],"upc":["0327241125027","0327241126024"],"nui":["N0000175427","N0000190114","N0000185503","N0000182137","N0000187061"],"pharm_class_epc":["Anti-anginal [EPC]"],"pharm_class_moa":["Cytochrome P450 3A Inhibitors [MoA]","P-Glycoprotein Inhibitors [MoA]","Cytochrome P450 2D6 Inhibitors [MoA]","Organic Cation Transporter 2 Inhibitors [MoA]"],"unii":["A6IEZ5M406"]},"product_type":"Drugs","event_id":"99893","recalling_firm":"Ajanta Pharma USA Inc","address_1":"400 Crossing Blvd Ste 102","address_2":"","postal_code":"08807-2863","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Nationwide in the US.","recall_number":"D-0010-2027","product_description":"Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807.  NDC: 27241-126-02","product_quantity":"","reason_for_recall":"Failed Dissolution Specifications: below specification","recall_initiation_date":"20260917","center_classification_date":"20261006","report_date":"20261007","code_info":"Lot: DJ25134, Exp 11/30/2028","more_code_info":""}]}}