{
  "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": "2026-07-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "East Brunswick",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA205756"
        ],
        "brand_name": [
          "METHYLPHENIDATE HYDROCHLORIDE"
        ],
        "generic_name": [
          "METHYLPHENIDATE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Rising Pharma Holdings, Inc."
        ],
        "product_ndc": [
          "64980-221",
          "64980-222",
          "64980-223"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "METHYLPHENIDATE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1091152",
          "1091322",
          "1091389"
        ],
        "spl_id": [
          "85d614b0-888e-461f-bc7d-3f240ed8bd0e"
        ],
        "spl_set_id": [
          "e5cb0740-813f-4dce-8c29-d7680c66e77c"
        ],
        "package_ndc": [
          "64980-221-01",
          "64980-222-01",
          "64980-223-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "4B3SC438HI"
        ]
      },
      "product_type": "Drugs",
      "event_id": "89545",
      "recalling_firm": "RISING PHARMACEUTICALS",
      "address_1": "2 Tower Center Blvd",
      "address_2": "",
      "postal_code": "08816-1100",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0573-2022",
      "product_description": "Methylphenidate Hydrochloride Chewable Tablets, 2.5 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., Saddle Brook, NJ 07863, NDC 64980-221-01",
      "product_quantity": "2220 100-count bottles",
      "reason_for_recall": "Failed Tablet Specifications: Recall of this drug product was voluntarily initiated by the manufacturer due to a market complaint, which stated that a tablet in the sealed bottle was twice larger in size when compared to the remaining tablets. This complaint is second of its kind.",
      "recall_initiation_date": "20220207",
      "center_classification_date": "20220222",
      "report_date": "20220302",
      "code_info": "lot# 25910009, Exp 01/2023",
      "more_code_info": ""
    }
  ]
}