{"recall":{"id":"fda-drug-99296","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Lupin Pharmaceuticals Inc. recalls Glucagon Emergency Kit for Low Blood Sugar","firm":"Lupin Pharmaceuticals Inc.","date":"2026-06-23","reported":"2026-07-08","status":"Ongoing","classification":"Class II","products":[{"name":"Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial, Diluent for Glucagon, 1 mL syringe, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin Limited, Nagpur - 441108, INDIA, NDC 70748-311-01","code":"Kit Lots: WB00010, Exp. Date Jan 2027; WB00017, WB00019, Exp. Date Feb 2027; WB00070, Exp. Date Jun 2027; WB00077, WB00078, Exp. Date Jul 2027; WB00130, Exp. Date Nov 2027.","quantity":"64,894 units","number":"D-0723-2026","classification":"Class II"}],"reason":"CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Nationwide within the U.S.","nationwide":true,"states":[],"units":"64,894 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=99296","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"39782bac6e8745cc","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=99296","record":[{"status":"Ongoing","city":"Naples","state":"FL","country":"United States","classification":"Class II","openfda":{"application_number":["ANDA214457"],"brand_name":["GLUCAGON"],"generic_name":["GLUCAGON"],"manufacturer_name":["Lupin Pharmaceuticals, Inc."],"product_ndc":["70748-311"],"product_type":["HUMAN PRESCRIPTION DRUG"],"rxcui":["310497"],"spl_id":["8acd9382-8718-476e-a625-799607cf84d3"],"spl_set_id":["3d8c92cf-9263-4126-8a5b-4cd761e31bc1"],"package_ndc":["70748-311-01","70748-309-01","70748-310-01"],"is_original_packager":[true],"upc":["0370748311011"]},"product_type":"Drugs","event_id":"99296","recalling_firm":"Lupin Pharmaceuticals Inc.","address_1":"5801 Pelican Bay Blvd Ste 500","address_2":"N/A","postal_code":"34108-2734","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"Nationwide within the U.S.","recall_number":"D-0723-2026","product_description":"Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial, Diluent for Glucagon, 1 mL syringe, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin Limited, Nagpur - 441108, INDIA, NDC 70748-311-01","product_quantity":"64,894 units","reason_for_recall":"CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.","recall_initiation_date":"20260623","center_classification_date":"20260723","report_date":"20260708","code_info":"Kit Lots: WB00010, Exp. Date Jan 2027; WB00017, WB00019, Exp. Date Feb 2027; WB00070, Exp. Date Jun 2027; WB00077, WB00078, Exp. Date Jul 2027; WB00130, Exp. Date Nov 2027."}]}}