{"recall":{"id":"fda-drug-99653","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Mylan Pharmaceuticals Inc recalls Prasugrel Tablets","firm":"Mylan Pharmaceuticals Inc","date":"2026-08-17","reported":"2026-09-09","status":"Ongoing","classification":"Class II","products":[{"name":"Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 0378-5186-93.","code":"Lot #: 3225272, Exp. September 30, 2026","quantity":"47,662 bottles","number":"D-0839-2026","classification":"Class II"}],"reason":"Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria","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":"47,662 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=99653","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"c01e00248289a012","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=99653","record":[{"status":"Ongoing","city":"Morgantown","state":"WV","country":"United States","classification":"Class II","openfda":{"application_number":["ANDA205927"],"brand_name":["PRASUGREL"],"generic_name":["PRASUGREL"],"manufacturer_name":["Mylan Pharmaceuticals Inc."],"product_ndc":["0378-5185","0378-5186"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"substance_name":["PRASUGREL HYDROCHLORIDE"],"rxcui":["855812","855818"],"spl_id":["9e234352-49b7-46e3-bc59-acf63e0a7a14"],"spl_set_id":["41a4e332-6725-4cb7-940a-8291cf56cfe4"],"package_ndc":["0378-5185-93","0378-5186-93"],"is_original_packager":[true],"upc":["0303785185932"],"unii":["G89JQ59I13"]},"product_type":"Drugs","event_id":"99653","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":"Nationwide within the U.S","recall_number":"D-0839-2026","product_description":"Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 0378-5186-93.","product_quantity":"47,662 bottles","reason_for_recall":"Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria","recall_initiation_date":"20260817","center_classification_date":"20260911","report_date":"20260909","code_info":"Lot #: 3225272, Exp. September 30, 2026","more_code_info":""}]}}