{
  "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": "Nashville",
      "state": "TN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA074453"
        ],
        "brand_name": [
          "METOPROLOL TARTRATE"
        ],
        "generic_name": [
          "METOPROLOL TARTRATE"
        ],
        "manufacturer_name": [
          "Westminster Pharmaceuticals, LLC"
        ],
        "product_ndc": [
          "69367-354",
          "69367-355"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "METOPROLOL TARTRATE"
        ],
        "rxcui": [
          "866511",
          "866514"
        ],
        "spl_id": [
          "451f6d3f-6a31-fb28-e063-6294a90a06a0"
        ],
        "spl_set_id": [
          "4d352c34-47f8-4662-9ac5-d5a32bd1660f"
        ],
        "package_ndc": [
          "69367-354-01",
          "69367-354-10",
          "69367-355-01",
          "69367-355-10"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0369367355018",
          "0369367354103",
          "0369367354011"
        ],
        "unii": [
          "W5S57Y3A5L"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97395",
      "recalling_firm": "Westminster Pharmaceuticals LLC",
      "address_1": "1321 Murfreesboro Pike Ste 607",
      "address_2": "N/A",
      "postal_code": "37217-2693",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Nationwide in the USA.",
      "recall_number": "D-0581-2025",
      "product_description": "Metoprolol Tartrate Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrapur, Gazipur, 1700 Bangladesh, Distributed by: Westminster Pharmaceuticals, LLC, Nashville, TN 37217, NDC 69367-354-10",
      "product_quantity": "16,672 1000-count bottles",
      "reason_for_recall": "CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.",
      "recall_initiation_date": "20250806",
      "center_classification_date": "20250812",
      "report_date": "20250820",
      "code_info": "Batch # R55230021, R55230031, R55230041, Exp Date: 9/30/25; Batch # R55230051, R55230061, R55230071, R55230081, R55230091, R55230101, R55230111, R55230121, R55230131, R55230141, Exp Date: 10/31/2025; Batch # R55230151, Exp Date: 11/30/25; Batch # R55240011, Exp Date: 12/31/25; Batch # R55240021, R55240031, R55240041, R55240051, R55240061, Exp Date: 6/30/26; Batch # R55240071, R55240081, R55240091, R55240101, R55240111, R55240121, Exp Date: 7/31/26",
      "more_code_info": ""
    }
  ]
}