{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "East Windsor",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA077095"
        ],
        "brand_name": [
          "METFORMIN HYDROCHLORIDE"
        ],
        "generic_name": [
          "METFORMIN HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Aurobindo Pharma Limited"
        ],
        "product_ndc": [
          "65862-008",
          "65862-009",
          "65862-010"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "METFORMIN HYDROCHLORIDE"
        ],
        "rxcui": [
          "861004",
          "861007",
          "861010"
        ],
        "spl_id": [
          "c535450c-12fd-478d-ad45-743c5badfc28"
        ],
        "spl_set_id": [
          "4ac6d01a-af26-44e7-ae2e-3618de0080aa"
        ],
        "package_ndc": [
          "65862-008-50",
          "65862-008-60",
          "65862-008-90",
          "65862-008-01",
          "65862-008-33",
          "65862-008-05",
          "65862-008-99",
          "65862-008-45",
          "65862-009-50",
          "65862-009-60",
          "65862-009-90",
          "65862-009-01",
          "65862-009-33",
          "65862-009-05",
          "65862-009-99",
          "65862-009-44",
          "65862-010-50",
          "65862-010-60",
          "65862-010-90",
          "65862-010-01",
          "65862-010-33",
          "65862-010-05",
          "65862-010-99",
          "65862-010-46"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0365862010018",
          "0365862009012",
          "0365862008015"
        ],
        "unii": [
          "786Z46389E"
        ]
      },
      "product_type": "Drugs",
      "event_id": "79119",
      "recalling_firm": "Aurobindo Pharma Ltd.",
      "address_1": "279 Princeton Hightstown Rd",
      "address_2": "N/A",
      "postal_code": "08520-1401",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the US",
      "recall_number": "D-0427-2018",
      "product_description": "Metformin Hydrochloride Tablets, USP 1000 mg, 500-count bottles, Rx Only,   Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North Dayton, NJ 08810, Manufactured by: Aurobindo Pharma Limited Unit -VII (SEZ)) Mahabubnagar (Dt)_509302 India, NDC 65862-010-05.",
      "product_quantity": "7476 bottles",
      "reason_for_recall": "Presence of Foreign Tablet: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg",
      "recall_initiation_date": "20180202",
      "center_classification_date": "20180216",
      "termination_date": "20210218",
      "report_date": "20180228",
      "code_info": "Lot#: MTSC17145-A, Exp. July 2021"
    }
  ]
}