{"recall":{"id":"fda-drug-99824","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Pfizer recalls Dopamine HCl Inj","firm":"Pfizer","date":"2026-09-04","reported":"2026-09-23","status":"Ongoing","classification":"Class II","products":[{"name":"Dopamine HCl Inj., USP, 200 mg/5 mL (40 mg/mL), 5 mL Single-dose, 25 vials per tray, Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, Vial NDC 0409-5820-11, Carton NDC 0409-5820-01.","code":"Lot # NL5230, Exp Date:10/2027","quantity":"N/A","number":"D-0853-2026","classification":"Class II"}],"reason":"Lack of Assurance of Sterility","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide.","nationwide":true,"states":[],"units":"N/A","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=99824","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"ac7eb3a7df9b82be","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=99824","record":[{"status":"Ongoing","city":"Manhattan","state":"NY","country":"United States","classification":"Class II","openfda":{"application_number":["NDA018132"],"brand_name":["DOPAMINE HYDROCHLORIDE"],"generic_name":["DOPAMINE HYDROCHLORIDE"],"manufacturer_name":["Hospira, Inc."],"product_ndc":["0409-5820","0409-9104"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["INTRAVENOUS"],"substance_name":["DOPAMINE HYDROCHLORIDE"],"rxcui":["1743938","1743941"],"spl_id":["7a125e39-1ecb-4c76-931a-efc9b5921d1c"],"spl_set_id":["1f306ad2-3606-4525-5a8a-ce78f426c1a2"],"package_ndc":["0409-5820-11","0409-5820-01","0409-9104-21","0409-9104-20"],"is_original_packager":[true],"unii":["7L3E358N9L"]},"product_type":"Drugs","event_id":"99824","recalling_firm":"Pfizer","address_1":"66 Hudson Blvd","address_2":"N/A","postal_code":"10001-2189","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide.","recall_number":"D-0853-2026","product_description":"Dopamine HCl Inj., USP, 200 mg/5 mL (40 mg/mL), 5 mL Single-dose, 25 vials per tray, Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, Vial NDC 0409-5820-11, Carton NDC 0409-5820-01.","product_quantity":"N/A","reason_for_recall":"Lack of Assurance of Sterility","recall_initiation_date":"20260904","center_classification_date":"20260917","report_date":"20260923","code_info":"Lot # NL5230, Exp Date:10/2027","more_code_info":""}]}}