{
  "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,
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  "results": [
    {
      "status": "Ongoing",
      "city": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
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        ],
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        ],
        "generic_name": [
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        ],
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        "route": [
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        "substance_name": [
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        "rxcui": [
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        "spl_set_id": [
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          "43598-096-04",
          "43598-096-05"
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        "is_original_packager": [
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        ],
        "upc": [
          "0343598096049"
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        "unii": [
          "RG277LF5B3"
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      },
      "product_type": "Drugs",
      "event_id": "95811",
      "recalling_firm": "Dr. Reddy's Laboratories, Inc.",
      "address_1": "107 College Rd E",
      "address_2": "",
      "postal_code": "08540-6623",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S. Nationwide",
      "recall_number": "D-0117-2025",
      "product_description": "Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-096-04.",
      "product_quantity": "7,233 bottles",
      "reason_for_recall": "Failed Impurities/Degradation Specifications",
      "recall_initiation_date": "20241122",
      "center_classification_date": "20241212",
      "report_date": "20241218",
      "code_info": "Lot #: T2300653, Exp 01/31/2025; T2303956, T2303750, Exp 06/30/2025; T2304190, T2304987, Exp 08/31/2025; T2302026, Exp 03/31/2025; T2302526, Exp 05/31/2025.",
      "more_code_info": ""
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}