{
  "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": [
          "2a84c550-aed8-4058-961f-351a5e4cf7a1"
        ],
        "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": "85840",
      "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": "Press Release",
      "distribution_pattern": "Product was distributed throughout the United States.",
      "recall_number": "D-1334-2020",
      "product_description": "Metformin Hydrochloride Extended-release Tablets USP, 500 mg, 60 count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD Manufactured by: Lupin Limited Goa INDIA (NDC 68180-336-07)",
      "product_quantity": "6,540 bottles",
      "reason_for_recall": "CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level",
      "recall_initiation_date": "20200611",
      "center_classification_date": "20200620",
      "termination_date": "20211223",
      "report_date": "20200701",
      "code_info": "Batch # G901203, exp. date 12/2020"
    }
  ]
}