{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Rahway",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA204569"
        ],
        "brand_name": [
          "BELSOMRA"
        ],
        "generic_name": [
          "SUVOREXANT"
        ],
        "manufacturer_name": [
          "Merck Sharp & Dohme LLC"
        ],
        "product_ndc": [
          "0006-0005",
          "0006-0033",
          "0006-0325",
          "0006-0335"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SUVOREXANT"
        ],
        "rxcui": [
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          "1547110",
          "1547112",
          "1547114",
          "1547116",
          "1547118",
          "1547573",
          "1547575"
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        "spl_id": [
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        "package_ndc": [
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          "0006-0005-13",
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          "0006-0033-30",
          "0006-0033-13",
          "0006-0325-10",
          "0006-0325-30",
          "0006-0325-13",
          "0006-0335-10",
          "0006-0335-30",
          "0006-0335-13"
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        "is_original_packager": [
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        "nui": [
          "N0000191000",
          "N0000190998",
          "N0000185503",
          "N0000190114"
        ],
        "pharm_class_epc": [
          "Orexin Receptor Antagonist [EPC]"
        ],
        "pharm_class_moa": [
          "Orexin Receptor Antagonists [MoA]",
          "P-Glycoprotein Inhibitors [MoA]",
          "Cytochrome P450 3A Inhibitors [MoA]"
        ],
        "unii": [
          "081L192FO9"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97254",
      "recalling_firm": "Merck & Co. Inc",
      "address_1": "126 E Lincoln Ave",
      "address_2": "N/A",
      "postal_code": "07065-4607",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "N/A",
      "distribution_pattern": "Nationwide in the USA and PR.",
      "recall_number": "D-0584-2025",
      "product_description": "Belsomra (suvorexant) tablets, 10mg, 30 Tablets in 3 Blister Cards per Carton, Each Blister Card contains 10 Tablets, Rx only, Merck Sharp & Dohme LLC, Rahway, NJ 07065, USA, NDC 0006-0033-10 (Shellpack and Print Mat Labels), 0006-0033-30 (Carton Label)",
      "product_quantity": "51,320 cartons",
      "reason_for_recall": "Failed Dissolution Specifications: potential for delayed dissolution of the dose after administration which may result in delayed release of the drug, delaying onset of sleep.",
      "recall_initiation_date": "20250721",
      "center_classification_date": "20250813",
      "report_date": "20250820",
      "code_info": "Lots 2090019 and 2123744, Exp. 4/30/2027",
      "more_code_info": ""
    }
  ]
}