{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-09-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "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",
          "76045-005",
          "76045-006",
          "76045-007",
          "76045-008"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS"
        ],
        "substance_name": [
          "MORPHINE SULFATE"
        ],
        "rxcui": [
          "894912",
          "894914",
          "998212",
          "998213",
          "1442790"
        ],
        "spl_id": [
          "286bce70-23cd-4d5b-989b-230d6cdd5a91"
        ],
        "spl_set_id": [
          "1f53de80-efc8-4930-b3e3-fba0d026af05"
        ],
        "package_ndc": [
          "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": ""
    }
  ]
}