{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "New Brunswick",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "BLA761234"
        ],
        "brand_name": [
          "OPDUALAG"
        ],
        "generic_name": [
          "NIVOLUMAB AND RELATLIMAB-RMBW"
        ],
        "manufacturer_name": [
          "E.R. Squibb & Sons, L.L.C."
        ],
        "product_ndc": [
          "0003-7125"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "NIVOLUMAB",
          "RELATLIMAB"
        ],
        "rxcui": [
          "2596778",
          "2596784"
        ],
        "spl_id": [
          "7c285448-d5b9-4eca-b117-0d791b1b4de3"
        ],
        "spl_set_id": [
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        ],
        "package_ndc": [
          "0003-7125-11"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000191260",
          "N0000191259",
          "N0000194003",
          "N0000194002"
        ],
        "pharm_class_epc": [
          "Programmed Death Receptor-1 Blocking Antibody [EPC]",
          "Lymphocyte Activation Gene-3 Blocker [EPC]"
        ],
        "pharm_class_moa": [
          "Programmed Death Receptor-1-directed Antibody Interactions [MoA]",
          "Lymphocyte Activation Gene-3 Antagonists [MoA]"
        ],
        "unii": [
          "31YO63LBSN",
          "AF75XOF6W3"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97839",
      "recalling_firm": "Bristol-Myers Squibb Company",
      "address_1": "1 Squibb Dr",
      "address_2": "",
      "postal_code": "08901-1588",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0097-2026",
      "product_description": "Opdualag (nivolumab and relatlimab-rmbw) injection, 240 mg and 80 mg/20 mL (12mg and 4mg/mL),Single Dose Vial, RX Only, Bristol-Myers Squibb Company, Princeton, NJ 08543, NDC 0003-7125-11",
      "product_quantity": "12,778 total vials",
      "reason_for_recall": "Lack of Assurance of Sterility.",
      "recall_initiation_date": "20251021",
      "center_classification_date": "20251023",
      "report_date": "20251029",
      "code_info": "Lot: 033A23B, Expiry: 4/30/2026",
      "more_code_info": ""
    }
  ]
}