{"recall":{"id":"fda-drug-99492","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Aurobindo Pharma USA Inc recalls Dicyclomine Hydrochloride Capsules","firm":"Aurobindo Pharma USA Inc","date":"2026-07-23","reported":"2026-08-12","status":"Ongoing","classification":"Class II","products":[{"name":"Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-719-99","code":"Batch # DMC125018A, Exp Date: 07/2027.","quantity":"6,408 bottles distributed to market","number":"D-0733-2026","classification":"Class II"}],"reason":"shortfill; reports of empty capsules.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide.","nationwide":true,"states":[],"units":"6,408 bottles distributed to market","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=99492","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"307dabdbe36b2e6c","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=99492","record":[{"status":"Ongoing","city":"East Windsor","state":"NJ","country":"United States","classification":"Class II","openfda":{"application_number":["ANDA040319"],"brand_name":["DICYCLOMINE HYDROCHLORIDE"],"generic_name":["DICYCLOMINE HYDROCHLORIDE"],"manufacturer_name":["Aurobindo Pharma Limited"],"product_ndc":["59651-719"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"substance_name":["DICYCLOMINE HYDROCHLORIDE"],"rxcui":["991061"],"spl_id":["ec746016-eed0-4e37-bb9c-cb430c8a7f07"],"spl_set_id":["ec746016-eed0-4e37-bb9c-cb430c8a7f07"],"package_ndc":["59651-719-01","59651-719-99"],"is_original_packager":[true],"upc":["0359651719015"],"unii":["CQ903KQA31"]},"product_type":"Drugs","event_id":"99492","recalling_firm":"Aurobindo Pharma USA Inc","address_1":"279 Princeton Hightstown Rd","address_2":"","postal_code":"08520-1401","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide.","recall_number":"D-0733-2026","product_description":"Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-719-99","product_quantity":"6,408 bottles distributed to market","reason_for_recall":"shortfill; reports of empty capsules.","recall_initiation_date":"20260723","center_classification_date":"20260804","report_date":"20260812","code_info":"Batch # DMC125018A, Exp Date: 07/2027.","more_code_info":""}]}}