{
  "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": "2026-06-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Berkeley Heights",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA203088"
        ],
        "brand_name": [
          "DULOXETINE"
        ],
        "generic_name": [
          "DULOXETINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Breckenridge Pharmaceutical, Inc."
        ],
        "product_ndc": [
          "51991-746",
          "51991-747",
          "51991-748",
          "51991-750"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DULOXETINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "596926",
          "596930",
          "596934",
          "616402"
        ],
        "spl_id": [
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        ],
        "spl_set_id": [
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        ],
        "package_ndc": [
          "51991-746-06",
          "51991-746-90",
          "51991-746-05",
          "51991-747-33",
          "51991-747-90",
          "51991-747-10",
          "51991-748-33",
          "51991-748-90",
          "51991-748-10",
          "51991-750-33",
          "51991-750-90",
          "51991-750-05",
          "51991-750-10"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "9044SC542W"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99108",
      "recalling_firm": "Breckenridge Pharmaceutical, Inc.",
      "address_1": "200 Connell Dr Ste 4200",
      "address_2": "N/A",
      "postal_code": "07922-2805",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0582-2026",
      "product_description": "Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-747-10",
      "product_quantity": "14,729 bottles.",
      "reason_for_recall": "CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit",
      "recall_initiation_date": "20260604",
      "center_classification_date": "20260608",
      "report_date": "20260617",
      "code_info": "Lot: 241180C, Exp. Date April 2027."
    }
  ]
}