{
  "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": "East Windsor",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA211053"
        ],
        "brand_name": [
          "NEBIVOLOL"
        ],
        "generic_name": [
          "NEBIVOLOL"
        ],
        "manufacturer_name": [
          "Aurobindo Pharma Limited"
        ],
        "product_ndc": [
          "59651-137",
          "59651-138",
          "59651-139",
          "59651-140"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "NEBIVOLOL HYDROCHLORIDE"
        ],
        "rxcui": [
          "387013",
          "751612",
          "751618",
          "827073"
        ],
        "spl_id": [
          "2690da17-6194-47ba-9078-e27821283ee2"
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        "spl_set_id": [
          "6e43a4e2-574e-4f4a-804d-e346b4edd2f1"
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        "package_ndc": [
          "59651-137-30",
          "59651-137-90",
          "59651-138-30",
          "59651-138-90",
          "59651-139-30",
          "59651-139-90",
          "59651-140-30",
          "59651-140-90"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0359651137307"
        ],
        "unii": [
          "JGS34J7L9I"
        ]
      },
      "product_type": "Drugs",
      "event_id": "95934",
      "recalling_firm": "Aurobindo Pharma USA Inc",
      "address_1": "279 Princeton Hightstown Rd",
      "address_2": "",
      "postal_code": "08520-1401",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0149-2025",
      "product_description": "Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520.  NDC:  59651-137-30",
      "product_quantity": "",
      "reason_for_recall": "CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.",
      "recall_initiation_date": "20241206",
      "center_classification_date": "20241216",
      "report_date": "20241225",
      "code_info": "Lot #: NB0224001A and NB0224001B, Exp. Date 04/2027",
      "more_code_info": ""
    }
  ]
}