{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Marietta",
      "state": "GA",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA205327"
        ],
        "brand_name": [
          "METHYLPHENIDATE HYDROCHLORIDE"
        ],
        "generic_name": [
          "METHYLPHENIDATE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Trigen Laboratories, LLC"
        ],
        "product_ndc": [
          "13811-706",
          "13811-709",
          "13811-707",
          "13811-708",
          "13811-710"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "METHYLPHENIDATE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1091155",
          "1091170",
          "1091185",
          "1091210",
          "1995461"
        ],
        "spl_id": [
          "da71a915-393d-4af3-9e41-3fd4a25dc652"
        ],
        "spl_set_id": [
          "c45dc1de-adfa-4b3c-a7dc-cffbc8eac74f"
        ],
        "package_ndc": [
          "13811-709-10",
          "13811-706-10",
          "13811-707-10",
          "13811-708-10",
          "13811-710-10",
          "13811-710-30"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0313811706109",
          "0313811708103"
        ],
        "unii": [
          "4B3SC438HI"
        ]
      },
      "product_type": "Drugs",
      "event_id": "79365",
      "recalling_firm": "Osmotica Pharmaceutical Corp",
      "address_1": "895 Sawyer Rd",
      "address_2": "N/A",
      "postal_code": "30062-2257",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0581-2018",
      "product_description": "Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count bottle, Rx only, Trigen Laboratories, LLC Bridgewater, NJ 08807. NDC 13811-708-10",
      "product_quantity": "19,664 100-bottles",
      "reason_for_recall": "Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tablets 36 mg found to contain 1 27 mg Methylphenidate HCL ER Tablet.",
      "recall_initiation_date": "20180228",
      "center_classification_date": "20180306",
      "termination_date": "20190501",
      "report_date": "20180314",
      "code_info": "Lots: 170231B, 170232A, 170233A, 170234A"
    }
  ]
}