{
  "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": "Woburn",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA078347"
        ],
        "brand_name": [
          "HALOPERIDOL LACTATE"
        ],
        "generic_name": [
          "HALOPERIDOL LACTATE"
        ],
        "manufacturer_name": [
          "Mylan Institutional LLC"
        ],
        "product_ndc": [
          "67457-426"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR"
        ],
        "substance_name": [
          "HALOPERIDOL LACTATE"
        ],
        "rxcui": [
          "1719646"
        ],
        "spl_id": [
          "78868903-4ca8-4da0-84bc-340726c9ea4e"
        ],
        "spl_set_id": [
          "909259a3-7627-4d1e-91d3-3363b3493599"
        ],
        "package_ndc": [
          "67457-426-00",
          "67457-426-12"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "6387S86PK3"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97977",
      "recalling_firm": "Safecor Health, LLC",
      "address_1": "317 New Boston St",
      "address_2": "",
      "postal_code": "01801-6231",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Distributed in Massachusetts",
      "recall_number": "D-0214-2026",
      "product_description": "Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx only, For Intramuscular Use Only,  Manufactured for: Mylan Institutional LLC, Morgantown, WV 26605.  NDC: 67457-426-12 with Safecor Health LLC KITCHECK RFID Tag attached with incorrect serial numbers:  KITCHECK 8001-03A3,00000000,003A-2560, and 8001-03A3,00000000,003A-2D3B.",
      "product_quantity": "800 1mL vials",
      "reason_for_recall": "Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.",
      "recall_initiation_date": "20251010",
      "center_classification_date": "20251202",
      "report_date": "20251210",
      "code_info": "Lot 25381993 and 25391516, Exp 12/31/2026",
      "more_code_info": ""
    }
  ]
}