{
  "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,
      "limit": 1,
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    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA077242"
        ],
        "brand_name": [
          "GABAPENTIN"
        ],
        "generic_name": [
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        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
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          "62756-138",
          "62756-139",
          "62756-202",
          "62756-204"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
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        "substance_name": [
          "GABAPENTIN"
        ],
        "spl_id": [
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        "package_ndc": [
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          "62756-137-05",
          "62756-137-04",
          "62756-137-01",
          "62756-138-02",
          "62756-138-03",
          "62756-138-05",
          "62756-138-04",
          "62756-138-01",
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          "62756-139-03",
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          "62756-204-01",
          "62756-204-03"
        ],
        "is_original_packager": [
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          "0362756202016",
          "0362756138025",
          "0362756137028",
          "0362756139022"
        ],
        "nui": [
          "N0000008486"
        ],
        "pharm_class_pe": [
          "Decreased Central Nervous System Disorganized Electrical Activity [PE]"
        ],
        "unii": [
          "6CW7F3G59X"
        ]
      },
      "product_type": "Drugs",
      "event_id": "96415",
      "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 in the USA",
      "recall_number": "D-0312-2025",
      "product_description": "Gabapentin Capsules, USP 400 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-139-05; b) 1000-count bottles, NDC 62756-139-04; Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India.",
      "product_quantity": "852 bottles",
      "reason_for_recall": "Cross Contamination",
      "recall_initiation_date": "20250304",
      "center_classification_date": "20250404",
      "report_date": "20250416",
      "code_info": "Lot # a) HAD1712B, Exp. date 03/2025 b) HAD1712C, exp. date 03/2025"
    }
  ]
}