{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "country": "United States",
      "city": "New York",
      "address_1": "235 East 42nd Street",
      "reason_for_recall": "CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit",
      "address_2": "",
      "product_quantity": "",
      "code_info": "Lots 00018522, 00018523, 00018739, 00018740, 00020231, 00020232, 00020357, 00020358, 00020716, 00020813, 00021288, 00021289, 00021420, 00021687, 00021688, 00021788, 00021789, 00021790, 00021791, 00021792, 00022819, 00022851, 00023136, 00023137, 00023190, 00023448, DM0275, DM0276, DM0277, DY4470, EC5911, EC5912, ED6814, ET1600, ET1603, ET1607, ET1609, ET1611  EXPIRATION DATE: August 2021   January 2023",
      "center_classification_date": "20210917",
      "distribution_pattern": "Nationwide",
      "state": "NY",
      "product_description": "Chantix (varenicline) tablets 0.5mg/1mg, 56 Tablets, Rx only,  Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 00069-0471-03.  carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42.1 mg tablets.",
      "report_date": "20210929",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Pfizer Inc.",
      "recall_number": "D-0808-2021",
      "initial_firm_notification": "Press Release",
      "product_type": "Drugs",
      "event_id": "88497",
      "more_code_info": "",
      "recall_initiation_date": "20210813",
      "postal_code": "10017-5703",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Ongoing"
    }
  ]
}