{"recall":{"id":"fda-drug-99711","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Hikma Pharmaceuticals USA INC. recalls Ramipril Capsules USP","firm":"Hikma Pharmaceuticals USA INC.","date":"2026-08-24","reported":"2026-09-02","status":"Ongoing","classification":"Class II","products":[{"name":"Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05) bottles, Rx only, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33432, Manufactured by: West-Ward Columbus Inc., Columbus, OH 43228.","code":"a) Lot #: AC5470A, Exp. Date July 2027 b) Lot #: AC5470B, Exp. Date July 2027","quantity":"a) 25,970 bottles; b) 2,384 bottles","number":"D-0831-2026","classification":"Class II"}],"reason":"Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).","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":"a) 25,970 bottles; b) 2,384 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=99711","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"f818e5dfd1e19ef6","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=99711","record":[{"status":"Ongoing","city":"Columbus","state":"OH","country":"United States","classification":"Class II","openfda":{"application_number":["ANDA077900"],"brand_name":["RAMIPRIL"],"generic_name":["RAMIPRIL"],"manufacturer_name":["Exelan Pharmaceuticals, Inc."],"product_ndc":["76282-670","76282-671","76282-672","76282-673"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"substance_name":["RAMIPRIL"],"rxcui":["198188","198189","261962","845488"],"spl_id":["37481fc5-771f-4dc7-aa06-6913ab75d485"],"spl_set_id":["1e1dfacf-b831-4743-a874-9a5e5ef8a120"],"package_ndc":["76282-670-01","76282-671-01","76282-671-05","76282-672-01","76282-672-05","76282-673-01","76282-673-05"],"is_original_packager":[true],"upc":["0376282670010","0376282672014","0376282673011"],"nui":["N0000175562","N0000000181"],"pharm_class_epc":["Angiotensin Converting Enzyme Inhibitor [EPC]"],"pharm_class_moa":["Angiotensin-converting Enzyme Inhibitors [MoA]"],"unii":["L35JN3I7SJ"]},"product_type":"Drugs","event_id":"99711","recalling_firm":"Hikma Pharmaceuticals USA INC.","address_1":"1809 Wilson Rd","address_2":"N/A","postal_code":"43228-9579","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Nationwide within the United States","recall_number":"D-0831-2026","product_description":"Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05) bottles, Rx only, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33432, Manufactured by: West-Ward Columbus Inc., Columbus, OH  43228.","product_quantity":"a) 25,970 bottles; b) 2,384 bottles","reason_for_recall":"Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).","recall_initiation_date":"20260824","center_classification_date":"20260903","report_date":"20260902","code_info":"a) Lot #: AC5470A, Exp. Date July 2027 b) Lot #: AC5470B, Exp. Date July 2027"}]}}