{
  "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": "Elmwood Park",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA215995"
        ],
        "brand_name": [
          "BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE"
        ],
        "generic_name": [
          "BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE"
        ],
        "manufacturer_name": [
          "GLENMARK PHARMACEUTICALS INC., USA"
        ],
        "product_ndc": [
          "68462-878",
          "68462-879",
          "68462-880"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "BISOPROLOL FUMARATE",
          "HYDROCHLOROTHIAZIDE"
        ],
        "rxcui": [
          "854908",
          "854916",
          "854919"
        ],
        "spl_id": [
          "6154a348-821d-46cc-a830-ac5684f9525a"
        ],
        "spl_set_id": [
          "ab73a6d8-2e33-4fdc-a896-6c68ab772da6"
        ],
        "package_ndc": [
          "68462-878-30",
          "68462-878-01",
          "68462-878-05",
          "68462-879-30",
          "68462-879-01",
          "68462-879-05",
          "68462-880-30",
          "68462-880-01",
          "68462-880-05"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368462880302",
          "0368462879306",
          "0368462878309"
        ],
        "nui": [
          "N0000175359",
          "N0000175419",
          "M0471776"
        ],
        "pharm_class_pe": [
          "Increased Diuresis [PE]"
        ],
        "pharm_class_epc": [
          "Thiazide Diuretic [EPC]"
        ],
        "pharm_class_cs": [
          "Thiazides [CS]"
        ],
        "unii": [
          "UR59KN573L",
          "0J48LPH2TH"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98036",
      "recalling_firm": "Glenmark Pharmaceuticals Inc., USA",
      "address_1": "619 River Dr",
      "address_2": "",
      "postal_code": "07407-1317",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0199-2026",
      "product_description": "Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-878-30; (b) 100-count bottle, NDC-68462-878-01; (c) 500-count bottles, NDC-68462-878-05; Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, Inda. Manufactured for: Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430.",
      "product_quantity": "11,136 bottles",
      "reason_for_recall": "Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe",
      "recall_initiation_date": "20251121",
      "center_classification_date": "20251201",
      "report_date": "20251210",
      "code_info": "Lot #: (a): Lot 17232401, exp 11/2025; Lot 17240974, exp 05/2026 (b): Lot 17232401, exp 11/2025; Lot 17240974, exp 05/2026 (c): Lot 17232401, exp 11/2025; Lot 17240974, exp 05/2026",
      "more_code_info": ""
    }
  ]
}