{"recall":{"id":"fda-drug-99483","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Mylan Pharmaceuticals Inc recalls Acamprosate Calcium","firm":"Mylan Pharmaceuticals Inc","date":"2026-07-24","reported":"2026-08-26","status":"Ongoing","classification":"Class II","products":[{"name":"Acamprosate Calcium, Delayed-Release Tablets, 333 mg, 180 tablets bottles, Rx only, Mylan Pharmaceuticals Inc., Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 266505, NDC 0378-6333-80.","code":"Lot# 3227809; Expiry:10/2026; NDC #: 0378-6333-80","quantity":"","number":"D-0774-2026","classification":"Class II"}],"reason":"Failed Dissolution Specifications","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide.","nationwide":true,"states":[],"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=99483","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"145a4bc9b62f5312","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=99483","record":[{"status":"Ongoing","city":"Morgantown","state":"WV","country":"United States","classification":"Class II","openfda":{"application_number":["ANDA200142"],"brand_name":["ACAMPROSATE CALCIUM"],"generic_name":["ACAMPROSATE CALCIUM ENTERIC-COATED"],"manufacturer_name":["Mylan Pharmaceuticals Inc."],"product_ndc":["0378-6333"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"substance_name":["ACAMPROSATE CALCIUM"],"rxcui":["835726"],"spl_id":["e06868f1-f40b-4762-bd52-53a5ba825619"],"spl_set_id":["75ddfd10-55b2-426e-bc74-3413cd0d7c94"],"package_ndc":["0378-6333-80"],"is_original_packager":[true],"upc":["0303786333806"],"unii":["59375N1D0U"]},"product_type":"Drugs","event_id":"99483","recalling_firm":"Mylan Pharmaceuticals Inc","address_1":"3711 Collins Ferry Rd","address_2":"","postal_code":"26505-2362","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide.","recall_number":"D-0774-2026","product_description":"Acamprosate Calcium, Delayed-Release Tablets, 333 mg, 180 tablets bottles, Rx only, Mylan Pharmaceuticals Inc., Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 266505, NDC 0378-6333-80.","product_quantity":"","reason_for_recall":"Failed Dissolution Specifications","recall_initiation_date":"20260724","center_classification_date":"20260819","report_date":"20260826","code_info":"Lot# 3227809; Expiry:10/2026; NDC #: 0378-6333-80","more_code_info":""}]}}