{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Dublin",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA090858"
        ],
        "brand_name": [
          "GABAPENTIN"
        ],
        "generic_name": [
          "GABAPENTIN"
        ],
        "manufacturer_name": [
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          "Cardinal Health 107, LLC"
        ],
        "product_ndc": [
          "0904-6665",
          "0904-6666",
          "0904-6667",
          "55154-3363",
          "55154-7992",
          "55154-7993"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
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        ],
        "substance_name": [
          "GABAPENTIN"
        ],
        "rxcui": [
          "310430",
          "310431",
          "310432"
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        "spl_id": [
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          "0904-6666-61",
          "0904-6667-61",
          "55154-3363-0",
          "55154-7992-0",
          "55154-7993-0"
        ],
        "original_packager_product_ndc": [
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          "67877-223",
          "67877-224",
          "0904-6665",
          "0904-6666",
          "0904-6667"
        ],
        "nui": [
          "N0000008486"
        ],
        "pharm_class_pe": [
          "Decreased Central Nervous System Disorganized Electrical Activity [PE]"
        ],
        "unii": [
          "6CW7F3G59X"
        ],
        "upc": [
          "0055154336307",
          "0055154799201"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97777",
      "recalling_firm": "The Harvard Drug Group LLC",
      "address_1": "7000 Cardinal Pl",
      "address_2": "",
      "postal_code": "43017-1091",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "",
      "distribution_pattern": "US Nationwide.",
      "recall_number": "D-0031-2026",
      "product_description": "Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61 (Blister pack), NDC 55154-3363-0 (Outer Bag).",
      "product_quantity": "",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .",
      "recall_initiation_date": "20251010",
      "center_classification_date": "20251017",
      "report_date": "20251029",
      "code_info": "Lot # M04989A [Bag], M04989 [Blister Pack], Exp Date: 02/2026; Lot # M05056A [Bag], M05056 [Blister Pack], Exp Date: 04/2026; Lot # M05150A [Bag], M05150 [Blister Pack], Exp Date: 07/2026; Lot # M05312A [Bag], M05312 [Blister Pack], and M05342A [Bag], M05342 [Blister Pack], Exp Date: 01/2027.",
      "more_code_info": ""
    }
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}