{
  "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": "Terminated",
      "city": "Baltimore",
      "state": "MD",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "ANDA205948"
        ],
        "brand_name": [
          "TYDEMY"
        ],
        "generic_name": [
          "DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM"
        ],
        "manufacturer_name": [
          "Lupin Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "68180-904"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "rxcui": [
          "1013628",
          "1050492",
          "1050493",
          "1999724"
        ],
        "spl_id": [
          "9229c82f-e84e-4805-90d2-a77e0fad63b5"
        ],
        "spl_set_id": [
          "e4766132-4faa-4f76-89fe-75d4a6fd737b"
        ],
        "package_ndc": [
          "68180-904-73",
          "68180-905-74",
          "68180-910-74",
          "68180-904-71"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368180904717"
        ]
      },
      "product_type": "Drugs",
      "event_id": "92588",
      "recalling_firm": "Lupin Pharmaceuticals Inc.",
      "address_1": "Harborplace Tower",
      "address_2": "111 S Calvert St Fl 21st",
      "postal_code": "21202-6174",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "USA nationwide.",
      "recall_number": "D-1081-2023",
      "product_description": "Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets 0.451 mg), packaged in 1 blister of 28 tablets each (NDC 68180-904-71) further packaged in a carton of 3 blisters (NDC 68180-904-73), Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by Lupin Limited, Pithampur (M.P.), INDIA",
      "product_quantity": "4,179 boxes/_ cartons per box/3 pouches each/28 blister per pouch",
      "reason_for_recall": "Failed Stability Specification and Failed Impurities/Degradation Specifications:  out of specification for inactive content ascorbic acid and MTHFRC-7impurity test",
      "recall_initiation_date": "20230623",
      "center_classification_date": "20230804",
      "termination_date": "20250128",
      "report_date": "20230809",
      "code_info": "Lot #: L200183, Exp 1/2024; L201560, Exp 9/2024"
    }
  ]
}