{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Pennington",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "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": "96860",
      "recalling_firm": "Zydus Pharmaceuticals (USA) Inc",
      "address_1": "73 Route 31 N",
      "address_2": "N/A",
      "postal_code": "08534-3601",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide -in the USA",
      "recall_number": "D-0442-2025",
      "product_description": "Esomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg, 30-count Single-Dose Packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-849-94",
      "product_quantity": "30,674 30 sachets/carton",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.",
      "recall_initiation_date": "20250513",
      "center_classification_date": "20250520",
      "report_date": "20250528",
      "code_info": "Lot #  M311638, Exp 07/2025, M400374, Exp 10/2025, M402496, Exp 02/2026, M407998, Exp 05/2026, M502247, Exp 11/2026, M414770, M414512, Exp 09/2026."
    }
  ]
}