{"recall":{"id":"fda-drug-99750","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Mylan Pharmaceuticals Inc recalls Carton label: Mycophenolate Mofetil for injection","firm":"Mylan Pharmaceuticals Inc","date":"2026-08-26","reported":"2026-09-09","status":"Ongoing","classification":"Class II","products":[{"name":"Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single Dose Vials, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505, Made in India, NDC 67457-386-81. Vial Label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, Single Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505, Made in India, NDC 67457-386-00.","code":"Lot: 3242616, Exp. April 2027; 8220216, Exp. Nov 2027","quantity":"11,336 units","number":"D-0830-2026","classification":"Class II"}],"reason":"Failed Dissolution Specifications","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"U.S. Nationwide","nationwide":true,"states":[],"units":"11,336 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=99750","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"e6552b14529a5f1e","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=99750","record":[{"status":"Ongoing","city":"Morgantown","state":"WV","country":"United States","classification":"Class II","openfda":{"application_number":["ANDA203859"],"brand_name":["MYCOPHENOLATE MOFETIL"],"generic_name":["MYCOPHENOLATE MOFETIL"],"manufacturer_name":["Mylan Institutional LLC"],"product_ndc":["67457-386"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["INTRAVENOUS"],"substance_name":["MYCOPHENOLATE MOFETIL"],"rxcui":["311881"],"spl_id":["4c643876-2577-4197-ac9b-81bab65d1362"],"spl_set_id":["da02b428-42a4-4007-b0b7-695f2db010f2"],"package_ndc":["67457-386-00","67457-386-81"],"is_original_packager":[true],"unii":["9242ECW6R0"]},"product_type":"Drugs","event_id":"99750","recalling_firm":"Mylan Pharmaceuticals Inc","address_1":"3711 Collins Ferry Rd","address_2":"N/A","postal_code":"26505-2362","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"U.S. Nationwide","recall_number":"D-0830-2026","product_description":"Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single Dose Vials, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505, Made in India, NDC 67457-386-81.  Vial Label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, Single Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505, Made in India, NDC 67457-386-00.","product_quantity":"11,336 units","reason_for_recall":"Failed Dissolution Specifications","recall_initiation_date":"20260826","center_classification_date":"20260903","report_date":"20260909","code_info":"Lot: 3242616, Exp. April 2027; 8220216, Exp. Nov 2027","more_code_info":""}]}}