{
  "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": "Columbus",
      "state": "OH",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA040054"
        ],
        "brand_name": [
          "METHOTREXATE SODIUM"
        ],
        "generic_name": [
          "METHOTREXATE SODIUM"
        ],
        "manufacturer_name": [
          "Hikma Pharmaceuticals USA Inc."
        ],
        "product_ndc": [
          "0054-4550",
          "0054-8550"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "METHOTREXATE SODIUM"
        ],
        "rxcui": [
          "105585"
        ],
        "spl_id": [
          "09f7cdcb-241e-4916-a68c-b4c452d3d640"
        ],
        "spl_set_id": [
          "d71b1856-99d8-4a9e-9189-f87b6675f80a"
        ],
        "package_ndc": [
          "0054-4550-25",
          "0054-4550-15",
          "0054-8550-25"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0300544550253"
        ],
        "unii": [
          "3IG1E710ZN"
        ]
      },
      "product_type": "Drugs",
      "event_id": "93223",
      "recalling_firm": "West-Ward Columbus Inc",
      "address_1": "1809 Wilson Rd",
      "address_2": "N/A",
      "postal_code": "43228-9579",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "MS, OH",
      "recall_number": "D-0066-2024",
      "product_description": "Methotrexate Tablets, USP, 2.5 mg, 10x10 Unit-Dose Tablets per carton, Rx only, Distributed by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724.  NDC: 0054-8550-25",
      "product_quantity": "2,673 cartons",
      "reason_for_recall": "Failed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two tablets demonstrating illegible tablet identification and scoring.",
      "recall_initiation_date": "20230922",
      "center_classification_date": "20231023",
      "report_date": "20231101",
      "code_info": "Lot, expiry:  Lot AB7486B, exp Dec 2023; Lot AB8766B, exp April 2024; Lot AB9484B, exp Aug 2024"
    }
  ]
}