{
  "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": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA215931"
        ],
        "brand_name": [
          "VARENICLINE TARTRATE"
        ],
        "generic_name": [
          "VARENICLINE TARTRATE"
        ],
        "manufacturer_name": [
          "Dr. Reddys Laboratories Inc."
        ],
        "product_ndc": [
          "43598-022",
          "43598-907",
          "43598-908",
          "43598-023"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "rxcui": [
          "636671",
          "636676",
          "749289",
          "749788"
        ],
        "spl_id": [
          "65233c50-9a25-15c3-cc2b-98713a8173b2"
        ],
        "spl_set_id": [
          "16ee0a83-88d7-97de-1e07-f9e6dcb5c934"
        ],
        "package_ndc": [
          "43598-907-56",
          "43598-908-56",
          "43598-023-53",
          "43598-022-56"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "82269ASB48"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97957",
      "recalling_firm": "Dr. Reddy's Laboratories, Inc.",
      "address_1": "600 College Rd E Ste 4000",
      "address_2": "N/A",
      "postal_code": "08540-6636",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distributed Nationwide",
      "recall_number": "D-0219-2026",
      "product_description": "Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56",
      "product_quantity": "4800 54-count bottles",
      "reason_for_recall": "Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was  below specification limit.",
      "recall_initiation_date": "20251111",
      "center_classification_date": "20251205",
      "report_date": "20251217",
      "code_info": "Lot # F2400244, Exp Date: 10/31/2026",
      "more_code_info": ""
    }
  ]
}