{
  "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": "Columbus",
      "state": "OH",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA088109"
        ],
        "brand_name": [
          "METHADONE HYDROCHLORIDE"
        ],
        "generic_name": [
          "METHADONE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Hikma Pharmaceuticals USA Inc."
        ],
        "product_ndc": [
          "0054-0709",
          "0054-0710"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "METHADONE HYDROCHLORIDE"
        ],
        "rxcui": [
          "864706",
          "864718"
        ],
        "spl_id": [
          "32014633-5c89-4163-9fa7-239777c04d1d"
        ],
        "spl_set_id": [
          "50f14803-78c0-4d19-8b5d-9a9c17582ac1"
        ],
        "package_ndc": [
          "0054-0709-25",
          "0054-0709-20",
          "0054-0710-25",
          "0054-0710-20"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0300540709259",
          "0300540710255"
        ],
        "unii": [
          "229809935B"
        ]
      },
      "product_type": "Drugs",
      "event_id": "95999",
      "recalling_firm": "West-Ward Columbus Inc",
      "address_1": "1809 Wilson Rd",
      "address_2": "",
      "postal_code": "43228-9579",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide.",
      "recall_number": "D-0183-2025",
      "product_description": "Methadone Hydrochloride Tablets, USP, 5mg, 10x10 Unit-Dose Tablets, Rx Only, Distributed by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0709-20",
      "product_quantity": "2591 100-count boxes",
      "reason_for_recall": "Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.",
      "recall_initiation_date": "20241219",
      "center_classification_date": "20250103",
      "report_date": "20250115",
      "code_info": "Lot # AC2556A; Exp. 03/2027",
      "more_code_info": ""
    }
  ]
}