{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Pennington",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA076900"
        ],
        "brand_name": [
          "ATENOLOL"
        ],
        "generic_name": [
          "ATENOLOL"
        ],
        "manufacturer_name": [
          "Zydus Pharmaceuticals USA Inc."
        ],
        "product_ndc": [
          "68382-022",
          "68382-023",
          "68382-024"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ATENOLOL"
        ],
        "rxcui": [
          "197379",
          "197380",
          "197381"
        ],
        "spl_id": [
          "860eb406-b330-4b72-b768-122d57c74293"
        ],
        "spl_set_id": [
          "db801706-1362-44c7-92ab-f584f96c7e1c"
        ],
        "package_ndc": [
          "68382-022-16",
          "68382-022-01",
          "68382-022-10",
          "68382-022-40",
          "68382-022-24",
          "68382-023-16",
          "68382-023-01",
          "68382-023-10",
          "68382-023-02",
          "68382-023-40",
          "68382-023-24",
          "68382-024-16",
          "68382-024-01",
          "68382-024-10",
          "68382-024-40"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000000161",
          "N0000175556"
        ],
        "pharm_class_moa": [
          "Adrenergic beta-Antagonists [MoA]"
        ],
        "pharm_class_epc": [
          "beta-Adrenergic Blocker [EPC]"
        ],
        "unii": [
          "50VV3VW0TI"
        ]
      },
      "product_type": "Drugs",
      "event_id": "76673",
      "recalling_firm": "Zydus Pharmaceuticals USA Inc",
      "address_1": "73 Route 31 N",
      "address_2": "",
      "postal_code": "08534-3601",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA and Puerto Rico.",
      "recall_number": "D-0605-2017",
      "product_description": "ATENOLOL Tablets, USP, 50 mg, packaged in a) 100-count bottles (NDC 68382-023-01) and b) 1000-count bottles (NDC 68382-023-10), Rx only, Manufactured by: Cadila Healthcare Ltd., India; Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ  08534.",
      "product_quantity": "9561 bottles",
      "reason_for_recall": "Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a paroxetine 20 mg tablet.",
      "recall_initiation_date": "20170306",
      "center_classification_date": "20170321",
      "termination_date": "20191105",
      "report_date": "20170329",
      "code_info": "Lot #: a) Z600724, Exp 04/18; Z600725, Exp 04/18",
      "more_code_info": ""
    }
  ]
}