{"recall":{"id":"fda-drug-100087","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"STRIDES PHARMA INC recalls Cinacalcet Tablets","firm":"STRIDES PHARMA INC","date":"2026-10-07","reported":"2026-10-28","status":"Ongoing","classification":"Class II","products":[{"name":"Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry, 605 014, India; Distributed by: Strides Pharma Inc. Bridgewater, NJ 08807, NDC 64380-883-04","code":"Lot # 7717825A, Expiry: 11/30/2028.","quantity":"49,488 30-count bottles","number":"D-0079-2027","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":"49,488 30-count 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=100087","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"c474f9b33ef49121","firstSeen":"2026-11-02T22:17:07.772Z","updatedAt":"2026-11-02T22:17:07.772Z","history":[]},"official":{"fetchedAt":"2026-11-02T22:17:07.772Z","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=100087","record":[{"status":"Ongoing","city":"Bridgewater","state":"NJ","country":"United States","classification":"Class II","openfda":{"application_number":["ANDA209226"],"brand_name":["CINACALCET"],"generic_name":["CINACALCET"],"manufacturer_name":["Strides Pharma Science Limited"],"product_ndc":["64380-883","64380-884","64380-885"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"substance_name":["CINACALCET HYDROCHLORIDE"],"rxcui":["432400","432401","432402"],"spl_id":["40332509-df24-41a0-a75c-86d556cf0c50"],"spl_set_id":["0ba47b6a-ba49-4d7a-82e1-1c6e49bfa5d7"],"package_ndc":["64380-883-04","64380-884-04","64380-885-04"],"is_original_packager":[true],"upc":["0364380885047","0364380883043","0364380884040"],"unii":["1K860WSG25"]},"product_type":"Drugs","event_id":"100087","recalling_firm":"STRIDES PHARMA INC","address_1":"200 Crossing Blvd Ste 110","address_2":"","postal_code":"08807-2861","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide","recall_number":"D-0079-2027","product_description":"Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry, 605 014, India; Distributed by: Strides Pharma Inc. Bridgewater, NJ 08807, NDC 64380-883-04","product_quantity":"49,488 30-count bottles","reason_for_recall":"Failed dissolution specifications","recall_initiation_date":"20261007","center_classification_date":"20261026","report_date":"20261028","code_info":"Lot # 7717825A, Expiry: 11/30/2028.","more_code_info":""}]}}