{
  "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 II",
      "openfda": {
        "application_number": [
          "ANDA078232"
        ],
        "brand_name": [
          "LOSARTAN POTASSIUM"
        ],
        "generic_name": [
          "LOSARTAN POTASSIUM"
        ],
        "manufacturer_name": [
          "Lupin Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "68180-210",
          "68180-211",
          "68180-212",
          "68180-376",
          "68180-377",
          "68180-378",
          "68180-307",
          "68180-308",
          "68180-309"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "LOSARTAN POTASSIUM"
        ],
        "rxcui": [
          "979480",
          "979485",
          "979492"
        ],
        "spl_id": [
          "38431fb6-7157-4be5-929a-0c65b7a29c55"
        ],
        "spl_set_id": [
          "e5886220-43b7-46e1-9034-5242ba245bd1"
        ],
        "package_ndc": [
          "68180-210-09",
          "68180-210-03",
          "68180-210-01",
          "68180-210-06",
          "68180-211-06",
          "68180-211-09",
          "68180-211-03",
          "68180-211-01",
          "68180-212-06",
          "68180-212-03",
          "68180-212-09",
          "68180-212-01",
          "68180-376-03",
          "68180-376-06",
          "68180-376-01",
          "68180-376-09",
          "68180-377-03",
          "68180-377-01",
          "68180-377-09",
          "68180-377-06",
          "68180-378-09",
          "68180-378-03",
          "68180-378-06",
          "68180-378-01",
          "68180-307-01",
          "68180-307-02",
          "68180-307-09",
          "68180-307-06",
          "68180-308-06",
          "68180-308-09",
          "68180-308-02",
          "68180-308-01",
          "68180-309-06",
          "68180-309-09",
          "68180-309-02",
          "68180-309-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368180212065",
          "0368180376033",
          "0368180210061",
          "0368180378037",
          "0368180308027",
          "0368180376095",
          "0368180211068",
          "0368180309024",
          "0368180377030"
        ],
        "unii": [
          "3ST302B24A"
        ]
      },
      "product_type": "Drugs",
      "event_id": "89916",
      "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": "Product was distributed nationwide",
      "recall_number": "D-0838-2022",
      "product_description": "Losartan Potassium Tablets USP, 25 mg, a) 90-count bottles (NDC# 68180-376-03), b) 1000-count bottles (NDC#  68180-376-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA.",
      "product_quantity": "657,336 bottles",
      "reason_for_recall": "CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits",
      "recall_initiation_date": "20220331",
      "center_classification_date": "20220503",
      "termination_date": "20230522",
      "report_date": "20220511",
      "code_info": "H001333, exp. date Nov-22  H002786, exp. date Jan-23  H101282, exp. date Feb-23  H001189, exp. date Nov-22  H002955, exp. date Jan-23  H101285, exp. date Feb-23  H001714, exp. date Dec-22  H000523, exp. date Jan-23  H101989, exp. date Mar-23  H001940, exp. date Dec-22  H003080, exp. date Jan-23  H101789, exp. date Mar-23  H002388, exp. date Jan-23  H100109, exp. date Feb-23   H002389, exp. date Jan-23  H100642, exp. date Feb-23   H000848, exp. date Nov-22,  H002002, exp. date Dec-22  H100110, exp. date Feb-23  H001190, exp. date Nov-22  H002003, exp. date Dec-22  H100111, exp. date Feb-23  H001191, exp. date Nov-22  H002489, exp. date Jan-23  H100146, exp. date Feb-23  H001192, exp. date Nov-22  H002390, exp. date Jan-23  H100147, exp. date Feb-23  H001058, exp. date Nov-22  H002486, exp. date Jan-23  H101283, exp. date Feb-23  H000985, exp. date Nov-22  H002487, exp. date Jan-23  H101284, exp. date Feb-23  H001059, exp. date Nov-22  H002488, exp. date Jan-23  H100643, exp. date Feb-23  H001275, exp. date Nov-22  H002787, exp. date Jan-23  H100644, exp. date Mar-23  H001715, exp. date Dec-22  H002957, exp. date Jan-23  H100869, exp. date Mar-23  H001716, exp. date Dec-22  H002958, exp. date Jan-23  H101990, exp. date Mar-23  H001717, exp. date Dec-22  H003079, exp. date Jan-23  H101991, exp. date Mar-23  H001718, exp. date Dec-22  H003121, exp. date Feb-23  H101992, exp. date Mar-23  H001941, exp. date Dec-22  H003122, exp. date   Feb-23   H000847, exp. date  Nov 2022"
    }
  ]
}