{
  "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": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA078279"
        ],
        "brand_name": [
          "ESOMEPRAZOLE MAGNESIUM"
        ],
        "generic_name": [
          "ESOMEPRAZOLE MAGNESIUM"
        ],
        "manufacturer_name": [
          "Dr. Reddy's Laboratories Inc"
        ],
        "product_ndc": [
          "43598-509",
          "43598-510"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ESOMEPRAZOLE MAGNESIUM"
        ],
        "rxcui": [
          "606726",
          "606730"
        ],
        "spl_id": [
          "bc23d230-ec98-ff25-5296-39e31fe9b775"
        ],
        "spl_set_id": [
          "15023261-51c8-2388-3439-48dace49ec02"
        ],
        "package_ndc": [
          "43598-509-30",
          "43598-509-90",
          "43598-509-10",
          "43598-510-30",
          "43598-510-90",
          "43598-510-10"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "R6DXU4WAY9"
        ]
      },
      "product_type": "Drugs",
      "event_id": "82065",
      "recalling_firm": "Dr. Reddy's Laboratories, Inc.",
      "address_1": "107 College Rd E",
      "address_2": "N/A",
      "postal_code": "08540-6623",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distributed Nationwide in the USA",
      "recall_number": "D-0995-2019",
      "product_description": "Esomeprazole Magnesium Delayed-Release Capsules USP, 40mg*, a) 90-count bottle (NDC 43598-510-90) b) 1000 count bottle (NDC 43598-510-10), Rx only, Mfd By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 INDIA.",
      "product_quantity": "40,592, 90 and 1,000 count  bottles",
      "reason_for_recall": "Discoloration: Esomeprazole Magnesium DR Capsules (40mg)  may contain brown pellets.",
      "recall_initiation_date": "20190206",
      "center_classification_date": "20190312",
      "termination_date": "20210126",
      "report_date": "20190220",
      "code_info": "Lot #: a) C800589, Exp 5/2019; C706058, Exp 03/2019  Lot #: b) C704873 Exp 02/2019; C800951, C800953 Exp 06/2019."
    }
  ]
}