{"recall":{"id":"fda-drug-99837","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"OurPharma LLC recalls fentaNYL Citrate","firm":"OurPharma LLC","date":"2026-09-03","reported":"2026-09-16","status":"Ongoing","classification":"Class II","products":[{"name":"fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in 100 mL, 0.9% NaCl Bag, OurPharma LLC, 2512 S. City Lake, Fayetteville, AR, NDC 73013-1013-01.","code":"Lot #: 101301260605, BUD: 12/9/2026.","quantity":"1,610 bags","number":"D-0864-2026","classification":"Class II"}],"reason":"Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2026) and the product expiry (12/09/2026).","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Nationwide within the U.S","nationwide":true,"states":[],"units":"1,610 bags","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=99837","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"bf0d1260069b0e95","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=99837","record":[{"status":"Ongoing","city":"Fayetteville","state":"AR","country":"United States","classification":"Class II","openfda":{},"product_type":"Drugs","event_id":"99837","recalling_firm":"OurPharma LLC","address_1":"2512 S City Lake Rd","address_2":"","postal_code":"72701-5013","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Nationwide within the U.S","recall_number":"D-0864-2026","product_description":"fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in 100 mL, 0.9% NaCl Bag, OurPharma LLC, 2512 S. City Lake, Fayetteville, AR, NDC 73013-1013-01.","product_quantity":"1,610 bags","reason_for_recall":"Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2026) and the product expiry (12/09/2026).","recall_initiation_date":"20260903","center_classification_date":"20260921","report_date":"20260916","code_info":"Lot #: 101301260605, BUD: 12/9/2026.","more_code_info":""}]}}