{"recall":{"id":"fda-drug-99562","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"SUN PHARMACEUTICAL INDUSTRIES INC recalls Carbamazepine Tablets","firm":"SUN PHARMACEUTICAL INDUSTRIES INC","date":"2026-08-03","reported":"2026-08-26","status":"Ongoing","classification":"Class II","products":[{"name":"Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC 51672-4005-3.","code":"Lot # AD94033, Exp Date: 5/31/2028.","quantity":"1968 Bottles (1000Tablets/Bottle)","number":"D-0770-2026","classification":"Class II"}],"reason":"CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide.","nationwide":true,"states":[],"units":"1968 Bottles (1000Tablets/Bottle)","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=99562","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"fed532bf24b49e71","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=99562","record":[{"status":"Ongoing","city":"Princeton","state":"NJ","country":"United States","classification":"Class II","openfda":{},"product_type":"Drugs","event_id":"99562","recalling_firm":"SUN PHARMACEUTICAL INDUSTRIES INC","address_1":"2 Independence Way","address_2":"","postal_code":"08540-6620","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide.","recall_number":"D-0770-2026","product_description":"Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC 51672-4005-3.","product_quantity":"1968 Bottles (1000Tablets/Bottle)","reason_for_recall":"CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing","recall_initiation_date":"20260803","center_classification_date":"20260818","report_date":"20260826","code_info":"Lot # AD94033, Exp Date: 5/31/2028.","more_code_info":""}]}}