{
  "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": "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": [
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        ],
        "unii": [
          "9044SC542W"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97797",
      "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": "U.S. Nationwide",
      "recall_number": "D-0100-2026",
      "product_description": "Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC  51991-748-10),Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain; Dist. by: Breckenridge Pharmaceutical, Inc., Berkeley Heights, NJ 07922.",
      "product_quantity": "172,263 bottles",
      "reason_for_recall": "CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.",
      "recall_initiation_date": "20251009",
      "center_classification_date": "20251024",
      "report_date": "20251105",
      "code_info": "90-count- Lot # 240721C; Exp. 02/28/2027   1000-count- Lot #230286C; Exp.02/28/2026"
    }
  ]
}