{
  "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": [
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          "1807917"
        ],
        "spl_id": [
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        ],
        "spl_set_id": [
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        ],
        "package_ndc": [
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          "68180-336-02",
          "68180-336-01",
          "68180-337-07",
          "68180-337-01",
          "68180-337-02"
        ],
        "is_original_packager": [
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        ],
        "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-1385-2020",
      "product_description": "Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 60 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-337-07",
      "product_quantity": "273,060 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 #   G807619 Jul-20  G807620 Jul-20  G807733 Jul-20  G807734 Jul-20  G807735 Jul-20  G807445 Jul-20  G807617 Jul-20  G807618 Jul-20  G808042 Jul-20  G808043 Jul-20  G807349 Jul-20  G807350 Jul-20  G807444 Jul-20  G807507 Jul-20  G807508 Jul-20  G807314 Jul-20  G807316 Jul-20  G807325 Jul-20  G807348 Jul-20  G807616 Jul-20  G807312 Jul-20  G807313 Jul-20  G807315 Jul-20  G808374 Aug-20  G808427 Aug-20  G808373 Aug-20  G808426 Aug-20  G900057 Oct-20  G900058 Oct-20  G900059 Oct-20  G900060 Oct-20  G900061 Oct-20  G900062 Oct-20  G900106 Oct-20  G900140 Oct-20  G900141 Oct-20  G900152 Oct-20  G809596 Oct-20  G809598 Oct-20  G810182 Oct-20  G810183 Oct-20  G810184 Oct-20  G810185 Oct-20  G810186 Oct-20  G810187 Oct-20  G810188 Oct-20  G810189 Oct-20  G809554 Oct-20  G809556 Oct-20  G809557 Oct-20  G809558 Oct-20  G809559 Oct-20  G809548 Oct-20  G809549 Oct-20  G809550 Oct-20  G809551 Oct-20  G809552 Oct-20  G809553 Oct-20  G809555 Oct-20  G901004 Dec-20  G901005 Dec-20  G901053 Dec-20  G901002 Dec-20  G901003 Dec-20  G903182 Mar-21  G903183 Mar-21  G903236 Mar-21  G903237 Mar-21  G903238 Mar-21  G903155 Mar-21  G903156 Mar-21  G903157 Mar-21  G903158 Mar-21  G903159 Mar-21  G903178 Mar-21  G903179 Mar-21  G903180 Mar-21  G903181 Mar-21  G903239 Mar-21  G001837 Jan-22  G001860 Jan-22  G001861 Jan-22  G001905 Jan-22  G001933 Jan-22  G001934 Jan-22  G001763 Jan-22  G001764 Jan-22  G001765 Jan-22  G001766 Jan-22  G001767 Jan-22  G001795 Jan-22  G001836 Jan-22"
    }
  ]
}