{
  "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": [
          "ANDA078245"
        ],
        "brand_name": [
          "LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE"
        ],
        "generic_name": [
          "LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE"
        ],
        "manufacturer_name": [
          "Lupin Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "68180-215",
          "68180-216",
          "68180-217"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "HYDROCHLOROTHIAZIDE",
          "LOSARTAN POTASSIUM"
        ],
        "rxcui": [
          "979464",
          "979468",
          "979471"
        ],
        "spl_id": [
          "6b0e9bc3-30a9-47ce-8cbe-c51404d51ae6"
        ],
        "spl_set_id": [
          "ee1eaaf6-050b-48af-942b-5e3451edc164"
        ],
        "package_ndc": [
          "68180-215-09",
          "68180-215-03",
          "68180-215-01",
          "68180-215-06",
          "68180-216-06",
          "68180-216-09",
          "68180-216-01",
          "68180-216-03",
          "68180-217-06",
          "68180-217-09",
          "68180-217-01",
          "68180-217-03"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368180215066",
          "0368180217060"
        ],
        "nui": [
          "N0000175359",
          "N0000175419",
          "M0471776"
        ],
        "pharm_class_pe": [
          "Increased Diuresis [PE]"
        ],
        "pharm_class_epc": [
          "Thiazide Diuretic [EPC]"
        ],
        "pharm_class_cs": [
          "Thiazides [CS]"
        ],
        "unii": [
          "3ST302B24A",
          "0J48LPH2TH"
        ]
      },
      "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-0841-2022",
      "product_description": "Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg  a) 30-count bottles (NDC# 68180-215-06)  b) 90-count bottles (NDC# 68180-215-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA.",
      "product_quantity": "1,214,016 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": "Lot #  H001149 4/30/2022 68180-215-06  H001602 5/31/2022 68180-215-06  H001884 6/30/2022 68180-215-06  H002539 8/31/2022 68180-215-06  H100944 4/30/2023 68180-215-06  H101054 4/30/2023 68180-215-06  H001150 4/30/2022 68180-215-09  H001151 4/30/2022 68180-215-09  H001152 4/30/2022 68180-215-09  H001532 5/31/2022 68180-215-09  H001533 5/31/2022 68180-215-09  H001534 5/31/2022 68180-215-09  H001535 5/31/2022 68180-215-09  H001536 5/31/2022 68180-215-09  H001603 5/31/2022 68180-215-09  H001604 5/31/2022 68180-215-09  H001605 5/31/2022 68180-215-09  H001606 5/31/2022 68180-215-09  H001607 5/31/2022 68180-215-09  H001608 5/31/2022 68180-215-09  H001885 6/30/2022 68180-215-09  H001886 6/30/2022 68180-215-09  H001887 6/30/2022 68180-215-09  H001888 6/30/2022 68180-215-09  H002171 7/31/2022 68180-215-09  H002172 7/31/2022 68180-215-09  H002173 7/31/2022 68180-215-09  H002174 7/31/2022 68180-215-09  H002175 7/31/2022 68180-215-09  H002540 8/31/2022 68180-215-09  H002541 8/31/2022 68180-215-09  H002542 8/31/2022 68180-215-09  H002543 8/31/2022 68180-215-09  H002544 8/31/2022 68180-215-09  H002545 8/31/2022 68180-215-09  H002976 10/31/2022 68180-215-09  H002977 10/31/2022 68180-215-09  H002978 10/31/2022 68180-215-09  H003131 11/30/2022 68180-215-09  H003132 11/30/2022 68180-215-09  H003133 11/30/2022 68180-215-09  H003134 11/30/2022 68180-215-09  H003135 11/30/2022 68180-215-09  H003136 11/30/2022 68180-215-09  H100302 1/31/2023 68180-215-09  H100303 1/31/2023 68180-215-09  H100304 1/31/2023 68180-215-09  H100340 1/31/2023 68180-215-09  H100341 1/31/2023 68180-215-09  H100657 2/28/2023 68180-215-09  H100658 2/28/2023 68180-215-09  H100659 2/28/2023 68180-215-09  H100660 2/28/2023 68180-215-09  H100661 2/28/2023 68180-215-09  H100662 2/28/2023 68180-215-09  H100945 4/30/2023 68180-215-09  H100946 4/30/2023 68180-215-09  H101051 4/30/2023 68180-215-09  H101052 4/30/2023 68180-215-09  H101053 4/30/2023 68180-215-09  H101055 4/30/2023 68180-215-09  H101056 4/30/2023 68180-215-09  H101057 4/30/2023 68180-215-09  H101058 4/30/2023 68180-215-09  H101286 5/31/2023 68180-215-09  H101287 5/31/2023 68180-215-09  H101288 5/31/2023 68180-215-09  H101289 5/31/2023 68180-215-09  H101581 6/30/2023 68180-215-09  H101582 6/30/2023 68180-215-09  H101583 6/30/2023 68180-215-09  H101584 7/31/2023 68180-215-09  H101585 7/31/2023 68180-215-09  H101790 7/31/2023 68180-215-09  H101791 7/31/2023 68180-215-09  H102078 8/31/2023 68180-215-09  H102079 8/31/2023 68180-215-09  H102080 9/30/2023 68180-215-09  H102118 9/30/2023 68180-215-09  H102119 9/30/2023 68180-215-09  H102120 9/30/2023 68180-215-09  H102125 9/30/2023 68180-215-09  H102126 9/30/2023 68180-215-09"
    }
  ]
}