{
  "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": "Baltimore",
      "state": "MD",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA090692"
        ],
        "brand_name": [
          "METFORMIN HYDROCHLORIDE"
        ],
        "generic_name": [
          "METFORMIN HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Lupin Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "68180-336",
          "68180-337"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "METFORMIN HYDROCHLORIDE"
        ],
        "rxcui": [
          "1807894",
          "1807917"
        ],
        "spl_id": [
          "8d44b37a-b1be-4b0f-808e-70c088f55331"
        ],
        "spl_set_id": [
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        ],
        "package_ndc": [
          "68180-336-07",
          "68180-336-02",
          "68180-336-01",
          "68180-337-07",
          "68180-337-01",
          "68180-337-02"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368180337072"
        ],
        "unii": [
          "786Z46389E"
        ]
      },
      "product_type": "Drugs",
      "event_id": "85998",
      "recalling_firm": "Lupin Pharmaceuticals Inc.",
      "address_1": "Harborplace Tower",
      "address_2": "111 S Calvert St Fl 21st",
      "postal_code": "21202-6174",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Product was distributed throughout the United States.",
      "recall_number": "D-1384-2020",
      "product_description": "Metformin Hydrochloride Extended-Release Tablets USP 500 mg, 60 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-336-07",
      "product_quantity": "59,568 bottles",
      "reason_for_recall": "CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level",
      "recall_initiation_date": "20200707",
      "center_classification_date": "20200714",
      "termination_date": "20211223",
      "report_date": "20200722",
      "code_info": "Batch #   G808293 Aug-20  G808284 Aug-20  G808285 Aug-20  G808343 Aug-20  G901201 Dec-20  G901202 Dec-20  G906915 Jul-21  G906913 Jul-21  G906914 Jul-21  G002135 Jan-22  G002849 Feb-22"
    }
  ]
}