{"recall":{"id":"fda-drug-99194","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"ACCORD HEALTHCARE, INC. recalls Levothyroxine Sodium Tablets","firm":"ACCORD HEALTHCARE, INC.","date":"2026-06-08","reported":"2026-07-08","status":"Ongoing","classification":"Class II","products":[{"name":"Levothyroxine Sodium Tablets, USP, 300 mcg (0.3mg), 90 Tablets bottles, Rx only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: lntas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-458-15.","code":"Lot # D2401522, Exp Date: 06/2026.","quantity":"6432 bottles","number":"D-0656-2026","classification":"Class II"}],"reason":"Subpotent Drug","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide.","nationwide":true,"states":[],"units":"6432 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=99194","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"fb83d0c574a0371a","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=99194","record":[{"status":"Ongoing","city":"Raleigh","state":"NC","country":"United States","classification":"Class II","openfda":{"application_number":["ANDA212399"],"brand_name":["LEVOTHYROXINE SODIUM"],"generic_name":["LEVOTHYROXINE SODIUM"],"manufacturer_name":["Accord Healthcare Inc."],"product_ndc":["16729-447","16729-458","16729-448","16729-449","16729-451","16729-450","16729-452","16729-453","16729-454","16729-455","16729-456","16729-457"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"substance_name":["LEVOTHYROXINE SODIUM"],"rxcui":["892246","892251","892255","966220","966221","966222","966224","966225","966248","966249","966253","966270"],"spl_id":["415fc774-31a5-124f-e063-6294a90a0e46"],"spl_set_id":["a6233381-3043-4e9a-aaa6-a6b105e5142b"],"package_ndc":["16729-458-15","16729-458-17","16729-447-15","16729-447-17","16729-448-15","16729-448-17","16729-449-15","16729-449-17","16729-451-15","16729-451-17","16729-450-15","16729-450-17","16729-452-15","16729-452-17","16729-453-15","16729-453-17","16729-454-15","16729-454-17","16729-455-15","16729-455-17","16729-456-15","16729-456-17","16729-457-15","16729-457-17"],"is_original_packager":[true],"upc":["0316729447157","0316729449151","0316729452151","0316729454155","0316729453158","0316729448154","0316729451154","0316729457156","0316729450157","0316729456159","0316729458153","0316729455152"],"unii":["9J765S329G"]},"product_type":"Drugs","event_id":"99194","recalling_firm":"ACCORD HEALTHCARE, INC.","address_1":"8041 Arco Corporate Dr Ste 200","address_2":"N/A","postal_code":"27617-2010","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide.","recall_number":"D-0656-2026","product_description":"Levothyroxine Sodium Tablets, USP, 300 mcg (0.3mg), 90 Tablets bottles, Rx only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: lntas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-458-15.","product_quantity":"6432 bottles","reason_for_recall":"Subpotent Drug","recall_initiation_date":"20260608","center_classification_date":"20260630","report_date":"20260708","code_info":"Lot # D2401522, Exp Date: 06/2026."}]}}