{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "East Windsor",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA206530"
        ],
        "brand_name": [
          "FAMOTIDINE"
        ],
        "generic_name": [
          "FAMOTIDINE"
        ],
        "manufacturer_name": [
          "Aurobindo Pharma Limited"
        ],
        "product_ndc": [
          "65862-859",
          "65862-860"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "FAMOTIDINE"
        ],
        "rxcui": [
          "284245",
          "310273"
        ],
        "spl_id": [
          "e0c726f6-8257-4dba-b2f9-d78d28097bd9"
        ],
        "spl_set_id": [
          "b0798337-1a73-415e-8416-613984ce5c65"
        ],
        "package_ndc": [
          "65862-859-30",
          "65862-859-01",
          "65862-859-05",
          "65862-859-99",
          "65862-859-10",
          "65862-859-78",
          "65862-860-30",
          "65862-860-01",
          "65862-860-05",
          "65862-860-99",
          "65862-860-10",
          "65862-860-78"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000000151",
          "N0000175784"
        ],
        "pharm_class_moa": [
          "Histamine H2 Receptor Antagonists [MoA]"
        ],
        "pharm_class_epc": [
          "Histamine-2 Receptor Antagonist [EPC]"
        ],
        "unii": [
          "5QZO15J2Z8"
        ]
      },
      "product_type": "Drugs",
      "event_id": "87193",
      "recalling_firm": "Aurobindo Pharma USA Inc.",
      "address_1": "279 Princeton Hightstown Rd",
      "address_2": "",
      "postal_code": "08520-1401",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "TX, CA, GA, PA",
      "recall_number": "D-0290-2021",
      "product_description": "Famotidine Tablets USP 40mg, 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India, NDC 65862-860-99",
      "product_quantity": "1296 bottles",
      "reason_for_recall": "Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a lot of famotidine 40mg.",
      "recall_initiation_date": "20210120",
      "center_classification_date": "20210226",
      "termination_date": "20231012",
      "report_date": "20210310",
      "code_info": "Lot #: P2000467, Exp 7/2022",
      "more_code_info": ""
    }
  ]
}