{
  "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": "New York",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA021928"
        ],
        "brand_name": [
          "CHANTIX"
        ],
        "generic_name": [
          "VARENICLINE TARTRATE"
        ],
        "manufacturer_name": [
          "Pfizer Laboratories Div Pfizer Inc"
        ],
        "product_ndc": [
          "0069-0468",
          "0069-0469",
          "0069-0471"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "VARENICLINE TARTRATE"
        ],
        "rxcui": [
          "636671",
          "636676",
          "637188",
          "637190",
          "749289",
          "749788",
          "795735",
          "795737"
        ],
        "spl_id": [
          "09cce88b-e4f0-48b7-ac05-54d97976b4c5"
        ],
        "spl_set_id": [
          "f0ff4f27-5185-4881-a749-c6b7a0ca5696"
        ],
        "package_ndc": [
          "0069-0468-56",
          "0069-0469-56",
          "0069-0469-28",
          "0069-0471-03",
          "0069-0471-28"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0300690469560",
          "0300690468563",
          "0300690471280"
        ],
        "unii": [
          "82269ASB48"
        ]
      },
      "product_type": "Drugs",
      "event_id": "88497",
      "recalling_firm": "Pfizer Inc.",
      "address_1": "235 East 42nd Street",
      "address_2": "",
      "postal_code": "10017-5703",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Press Release",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0809-2021",
      "product_description": "Chantix (varenicline) tablets 0.5mg, 56 Tablets, Rx only,  Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 0069-0468-56.",
      "product_quantity": "",
      "reason_for_recall": "CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit",
      "recall_initiation_date": "20210813",
      "center_classification_date": "20210917",
      "report_date": "20210929",
      "code_info": "Lots , CY6861, DM9007, DM9008,  EN5725, EN8362, EN8467  EXPIRATION DATE: January 2022 - May 2023",
      "more_code_info": ""
    }
  ]
}