{"recall":{"id":"fda-drug-99533","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Fresenius Kabi USA, LLC recalls Morphine Sulfate Injection","firm":"Fresenius Kabi USA, LLC","date":"2026-08-04","reported":"2026-08-26","status":"Ongoing","classification":"Class I","products":[{"name":"Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or Intravenous use, Rx only, Fresenius Kabi, Lake Zurich, IL. Unit of Use NDC Number 76045-004-01; Unit of Sale NDC Number 76045-004-11","code":"Lot #: 6402820, Exp. Date 12/2028","quantity":"625500 syringes","number":"D-0788-2026","classification":"Class I"}],"reason":"Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.","hazard":"FDA Class I: a reasonable probability that use or exposure will cause serious adverse health consequences or death (FDA definition).","affected":"Nationwide within the USA.","nationwide":true,"states":[],"units":"625500 syringes","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=99533","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"5032a15b02da5a29","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=99533","record":[{"status":"Ongoing","city":"Lake Zurich","state":"IL","country":"United States","classification":"Class I","openfda":{"application_number":["NDA204223"],"brand_name":["MORPHINE SULFATE"],"generic_name":["MORPHINE SULFATE"],"manufacturer_name":["Fresenius Kabi, USA LLC"],"product_ndc":["76045-004","76045-238","76045-005","76045-006","76045-007","76045-008"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["INTRAMUSCULAR","INTRAVENOUS"],"substance_name":["MORPHINE SULFATE"],"rxcui":["894912","894914","998212","998213","1442790","2752697"],"spl_id":["e61f6eb4-cc71-47d3-b2f6-5e689c773779"],"spl_set_id":["1f53de80-efc8-4930-b3e3-fba0d026af05"],"package_ndc":["76045-238-01","76045-238-10","76045-004-01","76045-004-11","76045-005-01","76045-005-11","76045-006-01","76045-006-11","76045-007-01","76045-007-11","76045-008-01","76045-008-11"],"is_original_packager":[true],"unii":["X3P646A2J0"]},"product_type":"Drugs","event_id":"99533","recalling_firm":"Fresenius Kabi USA, LLC","address_1":"3 Corporate Dr","address_2":"","postal_code":"60047-8930","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distribution_pattern":"Nationwide within the USA.","recall_number":"D-0788-2026","product_description":"Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or Intravenous use, Rx only, Fresenius Kabi, Lake Zurich, IL. Unit of Use NDC Number 76045-004-01; Unit of Sale NDC Number 76045-004-11","product_quantity":"625500 syringes","reason_for_recall":"Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.","recall_initiation_date":"20260804","center_classification_date":"20260824","report_date":"20260826","code_info":"Lot #: 6402820, Exp. Date 12/2028","more_code_info":""}]}}