{
  "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": "Terminated",
      "city": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA090710"
        ],
        "brand_name": [
          "METHYLPHENIDATE HYDROCHLORIDE"
        ],
        "generic_name": [
          "METHYLPHENIDATE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "57664-228",
          "57664-229",
          "57664-230"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "METHYLPHENIDATE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1091150",
          "1091392",
          "1091497"
        ],
        "spl_id": [
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        ],
        "spl_set_id": [
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        "package_ndc": [
          "57664-228-83",
          "57664-228-88",
          "57664-228-08",
          "57664-228-13",
          "57664-228-18",
          "57664-229-83",
          "57664-229-88",
          "57664-229-08",
          "57664-229-13",
          "57664-229-18",
          "57664-230-83",
          "57664-230-88",
          "57664-230-08",
          "57664-230-13",
          "57664-230-18"
        ],
        "is_original_packager": [
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        ],
        "upc": [
          "0357664228883",
          "0357664229880",
          "0357664230886"
        ],
        "unii": [
          "4B3SC438HI"
        ]
      },
      "product_type": "Drugs",
      "event_id": "92680",
      "recalling_firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
      "address_1": "2 Independence Way",
      "address_2": "N/A",
      "postal_code": "08540-6620",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0940-2023",
      "product_description": "Methylphenidate Hydrochloride Tablets, USP 20mg, Rx Only, 100 Tablets per bottle, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512, NDC 57664-230-88.",
      "product_quantity": "7313 bottles",
      "reason_for_recall": "Presence of Foreign Substance: Metal embedded in a tablet.",
      "recall_initiation_date": "20230713",
      "center_classification_date": "20230724",
      "termination_date": "20240212",
      "report_date": "20230802",
      "code_info": "Lot AC74459, Exp 07/31/2024"
    }
  ]
}