{
  "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": "2026-10-28",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Morgantown",
      "state": "WV",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA202516"
        ],
        "brand_name": [
          "TELMISARTAN AND AMLODIPINE"
        ],
        "generic_name": [
          "TELMISARTAN AND AMLODIPINE"
        ],
        "manufacturer_name": [
          "Mylan Pharmaceuticals Inc."
        ],
        "product_ndc": [
          "0378-1075",
          "0378-1076",
          "0378-1077",
          "0378-1078"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "TELMISARTAN",
          "AMLODIPINE BESYLATE"
        ],
        "rxcui": [
          "876514",
          "876519",
          "876524",
          "876529"
        ],
        "spl_id": [
          "c4f4323d-671d-478b-b088-008530932cee"
        ],
        "spl_set_id": [
          "ca60a4d5-ace7-4889-94ee-e2265fd63811"
        ],
        "package_ndc": [
          "0378-1075-93",
          "0378-1076-93",
          "0378-1077-93",
          "0378-1078-93"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0303781075930",
          "0303781076937",
          "0303781078931",
          "0303781077934"
        ],
        "nui": [
          "N0000000070",
          "N0000175561"
        ],
        "pharm_class_moa": [
          "Angiotensin 2 Receptor Antagonists [MoA]"
        ],
        "pharm_class_epc": [
          "Angiotensin 2 Receptor Blocker [EPC]"
        ],
        "unii": [
          "U5SYW473RQ",
          "864V2Q084H"
        ]
      },
      "product_type": "Drugs",
      "event_id": "100048",
      "recalling_firm": "Viatris, Inc.",
      "address_1": "3711 Collins Ferry Rd",
      "address_2": "",
      "postal_code": "26505-2362",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA.",
      "recall_number": "D-0049-2027",
      "product_description": "Telmisartan and Amlodipine, Tablets, USP, 40mg/5 mg, 30-count Bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA, Made in India, NDC 0378-1075-93.",
      "product_quantity": "21,620 30-count bottles",
      "reason_for_recall": "Superpotent Drug: potential for the Telmisartan content in these lots to exceed specifications",
      "recall_initiation_date": "20261001",
      "center_classification_date": "20261016",
      "report_date": "20261028",
      "code_info": "Lot # 3228113, 3228114, 3228115, Exp Date: Oct 31, 2026; Lot # 3228120, 3228121, Exp Date: Nov 30, 2026.",
      "more_code_info": ""
    }
  ]
}