{
  "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": "Mahwah",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA079019"
        ],
        "brand_name": [
          "ATOMOXETINE"
        ],
        "generic_name": [
          "ATOMOXETINE"
        ],
        "manufacturer_name": [
          "Northstar Rx LLC"
        ],
        "product_ndc": [
          "16714-755",
          "16714-756",
          "16714-757",
          "16714-758",
          "16714-759",
          "16714-760",
          "16714-761"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ATOMOXETINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "349591",
          "349592",
          "349593",
          "349594",
          "349595",
          "608139",
          "608143"
        ],
        "spl_id": [
          "35db9ce2-5084-4b5f-8bac-63915457cccc"
        ],
        "spl_set_id": [
          "133a4b65-762b-4712-baba-2442546f0379"
        ],
        "package_ndc": [
          "16714-755-01",
          "16714-756-01",
          "16714-757-01",
          "16714-758-01",
          "16714-759-01",
          "16714-760-01",
          "16714-761-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0316714760018",
          "0316714755014",
          "0316714756011",
          "0316714761015",
          "0316714757018"
        ],
        "unii": [
          "57WVB6I2W0"
        ]
      },
      "product_type": "Drugs",
      "event_id": "96194",
      "recalling_firm": "Glenmark Pharmaceuticals Inc., USA",
      "address_1": "750 Corporate Dr",
      "address_2": "N/A",
      "postal_code": "07430-2009",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the U.S",
      "recall_number": "D-0238-2025",
      "product_description": "Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-755-01.",
      "product_quantity": "120,000 bottles",
      "reason_for_recall": "CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.",
      "recall_initiation_date": "20250129",
      "center_classification_date": "20250220",
      "report_date": "20250226",
      "code_info": "Lot Numbers:  19232356, Exp.: 5/2025; 19233198, Exp.: 7/2025; 19234213, 19234232, Exp.: 9/2025; 19241445, Exp.: 3/2026; 19243033, 19243121, Exp.: 7/2026."
    }
  ]
}