{"recall":{"id":"fda-drug-100046","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Hikma Pharmaceuticals USA INC. recalls Abirtega (abiraterone acetate) USP","firm":"Hikma Pharmaceuticals USA INC.","date":"2026-10-06","reported":"2026-10-28","status":"Ongoing","classification":"Class II","products":[{"name":"Abirtega (abiraterone acetate) USP, 250 mg, 120-count bottles, Rx only, Rx only, Mfd for: Hikma Pharmaceuticals USA Inc., Berkley Heights, NJ 07922 USA by: Arab Pharmaceuticals Manufacturing PSC PO Box 41, Sahab-Jordon, NDC 82249-011-12.","code":"Lot #: 3047, Exp Date July 2027.","quantity":"2136 bottles","number":"D-0076-2027","classification":"Class II"}],"reason":"Failed Tablet/Capsule Specifications: Failed tablet specifications for weight uniformity.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Nationwide within the United States","nationwide":true,"states":[],"units":"2136 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=100046","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"d9b2ad5648026d40","firstSeen":"2026-11-02T22:17:07.772Z","updatedAt":"2026-11-02T22:17:07.772Z","history":[]},"official":{"fetchedAt":"2026-11-02T22:17:07.772Z","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=100046","record":[{"status":"Ongoing","city":"Columbus","state":"OH","country":"United States","classification":"Class II","openfda":{"application_number":["ANDA208339"],"brand_name":["ABIRTEGA"],"generic_name":["ABIRATERONE ACETATE"],"manufacturer_name":["CivicaScript, LLC"],"product_ndc":["82249-011"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"substance_name":["ABIRATERONE ACETATE"],"rxcui":["1100075","2702601"],"spl_id":["692d596d-5465-4611-82f7-5d50c37270a2"],"spl_set_id":["2f932015-28b2-4f44-ac04-772e982e13e9"],"package_ndc":["82249-011-12"],"is_original_packager":[true],"upc":["0382249011123"],"unii":["EM5OCB9YJ6"]},"product_type":"Drugs","event_id":"100046","recalling_firm":"Hikma Pharmaceuticals USA INC.","address_1":"1809 Wilson Rd","address_2":"","postal_code":"43228-9579","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Nationwide within the United States","recall_number":"D-0076-2027","product_description":"Abirtega (abiraterone acetate) USP, 250 mg, 120-count bottles, Rx only, Rx only, Mfd for: Hikma Pharmaceuticals USA Inc., Berkley Heights, NJ 07922 USA by: Arab Pharmaceuticals Manufacturing PSC PO Box 41, Sahab-Jordon, NDC 82249-011-12.","product_quantity":"2136 bottles","reason_for_recall":"Failed Tablet/Capsule Specifications: Failed tablet specifications for weight uniformity.","recall_initiation_date":"20261006","center_classification_date":"20261023","report_date":"20261028","code_info":"Lot #: 3047, Exp Date July 2027.","more_code_info":""}]}}