{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Pennington",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA206055"
        ],
        "brand_name": [
          "ESOMEPRAZOLE MAGNESIUM"
        ],
        "generic_name": [
          "ESOMEPRAZOLE MAGNESIUM"
        ],
        "manufacturer_name": [
          "Zydus Pharmaceuticals USA Inc."
        ],
        "product_ndc": [
          "68382-848",
          "68382-849"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ESOMEPRAZOLE MAGNESIUM DIHYDRATE"
        ],
        "rxcui": [
          "692576",
          "692578"
        ],
        "spl_id": [
          "bc31956a-671b-4ca3-b9dd-1fdb03003cae"
        ],
        "spl_set_id": [
          "190a4c5b-1547-45d7-b00b-10da4131e2e2"
        ],
        "package_ndc": [
          "68382-848-94",
          "68382-849-94"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "36H71644EQ"
        ]
      },
      "product_type": "Drugs",
      "event_id": "95767",
      "recalling_firm": "Zydus Pharmaceuticals (USA) Inc",
      "address_1": "73 Route 31 N",
      "address_2": "",
      "postal_code": "08534-3601",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "USA Nationwide.",
      "recall_number": "D-0102-2025",
      "product_description": "Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-849-94.  Packaged in sachets",
      "product_quantity": "4404 packs",
      "reason_for_recall": "Labeling: Not Elsewhere Classified - Wrong NDC number",
      "recall_initiation_date": "20241114",
      "center_classification_date": "20241204",
      "report_date": "20241211",
      "code_info": "Lot#: M408002, Exp 05/31/2026",
      "more_code_info": ""
    }
  ]
}