{
  "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 III",
      "openfda": {
        "application_number": [
          "ANDA201586"
        ],
        "brand_name": [
          "TELMISARTAN AND AMLODIPINE"
        ],
        "generic_name": [
          "TELMISARTAN AND AMLODIPINE"
        ],
        "manufacturer_name": [
          "Lupin Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "68180-196",
          "68180-197",
          "68180-198",
          "68180-199"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "AMLODIPINE BESYLATE",
          "TELMISARTAN"
        ],
        "rxcui": [
          "876514",
          "876519",
          "876524",
          "876529"
        ],
        "spl_id": [
          "17a6182b-5050-470e-aa1d-1605fa9e088e"
        ],
        "spl_set_id": [
          "a97fefa6-99e6-4eb7-9393-ab2252a2c7d8"
        ],
        "package_ndc": [
          "68180-196-06",
          "68180-196-09",
          "68180-196-12",
          "68180-197-06",
          "68180-197-09",
          "68180-197-12",
          "68180-197-07",
          "68180-198-06",
          "68180-198-09",
          "68180-198-12",
          "68180-199-06",
          "68180-199-09",
          "68180-199-12"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368180196068"
        ],
        "nui": [
          "N0000000070",
          "N0000175561"
        ],
        "pharm_class_moa": [
          "Angiotensin 2 Receptor Antagonists [MoA]"
        ],
        "pharm_class_epc": [
          "Angiotensin 2 Receptor Blocker [EPC]"
        ],
        "unii": [
          "864V2Q084H",
          "U5SYW473RQ"
        ]
      },
      "product_type": "Drugs",
      "event_id": "82528",
      "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": "Letter",
      "distribution_pattern": "Product was distributed to 6 wholesalers/ drug chains and 2 mail order pharmacies that may have further distribute the product throughout the United States.",
      "recall_number": "D-1121-2019",
      "product_description": "Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablet bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by : Lupin Limited, Goa, INDIA -- NDC 68180-198-06",
      "product_quantity": "12,504 bottles",
      "reason_for_recall": "Failed Impurities/Degradation Specifications; 18 month long term stability study.",
      "recall_initiation_date": "20190401",
      "center_classification_date": "20190411",
      "termination_date": "20200701",
      "report_date": "20190417",
      "code_info": "G705843 Exp. date April, 2019  G707763 Exp. date August, 2019  G800434 Exp. date November, 2019"
    }
  ]
}