{"recall":{"id":"fda-drug-99385","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Ascend Laboratories, LLC recalls Amlodipine and Olmesartan Medoxomil Tablets","firm":"Ascend Laboratories, LLC","date":"2026-07-08","reported":"2026-07-29","status":"Ongoing","classification":"Class II","products":[{"name":"Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC., Parsnippany, NJ 07054. NDC: 67877-500-30","code":"Lot 25121311, expiry 3/31/2028","quantity":"6,192 bottles","number":"D-0712-2026","classification":"Class II"}],"reason":"Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Nationwide in the USA","nationwide":true,"states":[],"units":"6,192 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=99385","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"da822d24d9695632","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=99385","record":[{"status":"Ongoing","city":"Bedminster","state":"NJ","country":"United States","classification":"Class II","openfda":{"application_number":["ANDA209042"],"brand_name":["AMLODIPINE AND OLMESARTAN MEDOXOMIL"],"generic_name":["AMLODIPINE AND OLMESARTAN MEDOXOMIL"],"manufacturer_name":["Ascend Laboratories, LLC"],"product_ndc":["67877-499","67877-500","67877-501","67877-502"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"substance_name":["AMLODIPINE BESYLATE","OLMESARTAN MEDOXOMIL"],"rxcui":["730861","730866","730869","730872"],"spl_id":["32238052-6c4c-4b29-a59e-524c819c69f1"],"spl_set_id":["c1204fbe-d086-43cf-bbaa-efec9cd0487c"],"package_ndc":["67877-499-30","67877-499-90","67877-500-30","67877-500-90","67877-501-30","67877-501-90","67877-502-30","67877-502-90"],"is_original_packager":[true],"unii":["6M97XTV3HD","864V2Q084H"]},"product_type":"Drugs","event_id":"99385","recalling_firm":"Ascend Laboratories, LLC","address_1":"135 Us Highway 202 206 Ste 15","address_2":"N/A","postal_code":"07921-2608","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Nationwide in the USA","recall_number":"D-0712-2026","product_description":"Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC., Parsnippany, NJ 07054.  NDC: 67877-500-30","product_quantity":"6,192 bottles","reason_for_recall":"Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications","recall_initiation_date":"20260708","center_classification_date":"20260720","report_date":"20260729","code_info":"Lot 25121311, expiry 3/31/2028"}]}}