{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Somerset",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA203602"
        ],
        "brand_name": [
          "MORPHINE SULFATE"
        ],
        "generic_name": [
          "MORPHINE SULFATE"
        ],
        "manufacturer_name": [
          "Lupin Pharmaceuticals,Inc."
        ],
        "product_ndc": [
          "43386-540",
          "43386-541",
          "43386-542",
          "43386-543",
          "43386-544"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "MORPHINE SULFATE"
        ],
        "rxcui": [
          "891874",
          "891881",
          "891888",
          "891893",
          "892646"
        ],
        "spl_id": [
          "d4efe614-fe99-4cc7-b3ba-87c4e010efbd"
        ],
        "spl_set_id": [
          "d360a33f-6323-4b10-9e81-07e2813c2dbd"
        ],
        "package_ndc": [
          "43386-540-01",
          "43386-540-05",
          "43386-541-01",
          "43386-541-05",
          "43386-542-01",
          "43386-542-05",
          "43386-543-01",
          "43386-543-05",
          "43386-544-01",
          "43386-544-05"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0343386542017",
          "0343386543014",
          "0343386540013",
          "0343386541010"
        ],
        "unii": [
          "X3P646A2J0"
        ]
      },
      "product_type": "Drugs",
      "event_id": "82581",
      "recalling_firm": "LUPIN SOMERSET",
      "address_1": "400 Campus Dr",
      "address_2": "N/A",
      "postal_code": "08873-1145",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Product was shipped to 5 wholesalers and one Supermarket Chain who may have further distributed the product throughout the United States.",
      "recall_number": "D-1246-2019",
      "product_description": "Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202  NDC 43386-543-01",
      "product_quantity": "3,444 bottles",
      "reason_for_recall": "Failed Impurities/Degradation Specifications",
      "recall_initiation_date": "20190410",
      "center_classification_date": "20190425",
      "termination_date": "20221014",
      "report_date": "20190501",
      "code_info": "Lot#:  S700223 Exp. Apr 30 2019; S800467, Exp. Mar 31 2020."
    }
  ]
}