{
  "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": "2026-06-24",
    "results": {
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  "results": [
    {
      "status": "Ongoing",
      "city": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA021802"
        ],
        "brand_name": [
          "FOCALIN"
        ],
        "generic_name": [
          "DEXMETHYLPHENIDATE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
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        ],
        "product_ndc": [
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          "66758-240",
          "66758-239",
          "66758-241",
          "66758-242",
          "66758-237",
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          "66758-238"
        ],
        "product_type": [
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        ],
        "route": [
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        "substance_name": [
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        ],
        "rxcui": [
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        "is_original_packager": [
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        ]
      },
      "product_type": "Drugs",
      "event_id": "99121",
      "recalling_firm": "Sandoz Inc",
      "address_1": "100 College Rd W",
      "address_2": "",
      "postal_code": "08540-6604",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
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      "recall_number": "D-0608-2026",
      "product_description": "Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal CDMO Gainesville, LLC, Gainesville, GA 30504.  NDC: 66758-235-31",
      "product_quantity": "7,803 bottles",
      "reason_for_recall": "Labeling: Incorrect or Missing Lot and/or Exp Date",
      "recall_initiation_date": "20260601",
      "center_classification_date": "20260622",
      "report_date": "20260624",
      "code_info": "Lot VA0099422; Exp. Date June 30, 2028",
      "more_code_info": ""
    }
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}