{"recall":{"id":"fda-drug-99233","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Boehringer Ingelheim Pharmaceuticals, Inc. recalls Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets)","firm":"Boehringer Ingelheim Pharmaceuticals, Inc.","date":"2026-06-12","reported":"2026-07-08","status":"Ongoing","classification":"Class II","products":[{"name":"Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets), 12.5/1000 mg, 60 Tablets per Bottle, Rx only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. NDC: 00597-0300-45","code":"Lot 3244413; Exp. 12/31/2028","quantity":"560 bottles","number":"D-0657-2026","classification":"Class II"}],"reason":"CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been used for a different product.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"OH","nationwide":false,"states":["OH"],"units":"560 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=99233","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"7e170198c9fcef8c","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=99233","record":[{"status":"Ongoing","city":"Ridgefield","state":"CT","country":"United States","classification":"Class II","openfda":{},"product_type":"Drugs","event_id":"99233","recalling_firm":"Boehringer Ingelheim Pharmaceuticals, Inc.","address_1":"900 Ridgebury Rd","address_2":"N/A","postal_code":"06877-1058","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"OH","recall_number":"D-0657-2026","product_description":"Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets), 12.5/1000 mg, 60 Tablets per Bottle, Rx only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA.  NDC: 00597-0300-45","product_quantity":"560 bottles","reason_for_recall":"CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been used for a different product.","recall_initiation_date":"20260612","center_classification_date":"20260630","report_date":"20260708","code_info":"Lot 3244413; Exp. 12/31/2028"}]}}