{
  "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": [
          "ANDA091664"
        ],
        "brand_name": [
          "METFORMIN HYDROCHLORIDE"
        ],
        "generic_name": [
          "METFORMIN HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Lupin Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "68180-338",
          "68180-339"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "METFORMIN HYDROCHLORIDE"
        ],
        "rxcui": [
          "1807888",
          "1807915"
        ],
        "spl_id": [
          "2da9ae97-97e8-43fe-b92a-00f3f7c25673"
        ],
        "spl_set_id": [
          "1200ea71-8a9e-4e49-bb77-7d9fe0d84ae7"
        ],
        "package_ndc": [
          "68180-338-01",
          "68180-338-02",
          "68180-338-03",
          "68180-339-09",
          "68180-339-01",
          "68180-339-02"
        ],
        "is_original_packager": [
          true
        ],
        "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-1382-2020",
      "product_description": "Metformin Hydrochloride Extended-release Tablets USP 500 mg, 100 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-338-01",
      "product_quantity": "64,344 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#  G808201 Aug-20  G808202 Aug-20  G808200 Aug-20  G900935 Dec-20  G901311 Dec-20  G900957 Dec-20  G900958 Dec-20  G901006 Dec-20  G904803 May-21  G904804 May-21  G906551 Jul-21   G906552 Jul-21  G907375 Aug-21  G908605 Oct-21  G908604 Oct-21   G002108 Jan-22  G002109 Jan-22  G002559 Feb-22  G002560 Feb-22"
    }
  ]
}