{
  "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": "Baltimore",
      "state": "MD",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA065234"
        ],
        "brand_name": [
          "CEPHALEXIN"
        ],
        "generic_name": [
          "CEPHALEXIN"
        ],
        "manufacturer_name": [
          "Lupin Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "68180-440",
          "68180-123",
          "68180-124",
          "68180-441"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CEPHALEXIN"
        ],
        "spl_id": [
          "78aee1aa-f859-489e-98b5-78af55b92374"
        ],
        "spl_set_id": [
          "25ef498a-7a7e-4543-a544-b9d0e99f9cd9"
        ],
        "package_ndc": [
          "68180-123-01",
          "68180-123-02",
          "68180-124-01",
          "68180-124-02",
          "68180-440-01",
          "68180-440-02",
          "68180-441-01",
          "68180-441-02"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "OBN7UDS42Y"
        ]
      },
      "product_type": "Drugs",
      "event_id": "81908",
      "recalling_firm": "Lupin Pharmaceuticals Inc.",
      "address_1": "111 S Calvert St Fl 21ST",
      "address_2": "N/A",
      "postal_code": "21202-6174",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Product was distributed to 5 wholesalers, 2 drug chains and 1 supermarket who may have further distributed the product throughout the United States.",
      "recall_number": "D-0423-2019",
      "product_description": "Cephalexin for Oral Suspension USP 250mg/5 mL, Rx Only   Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland,  Manufactured by: Lupin Limited Mandideep 462 046 India ---  NDC 68180-441-01",
      "product_quantity": "14,400 bottles",
      "reason_for_recall": "CGMP Deviations; presence of extraneous material in the  was observed in area that is between the primary package that is heat sealed and secondary packaging (poly-woven bag) of sucrose (an excipient) used in the finished product.",
      "recall_initiation_date": "20190109",
      "center_classification_date": "20190131",
      "termination_date": "20200408",
      "report_date": "20190206",
      "code_info": "lot F801282, Expiry June 2020"
    }
  ]
}