{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Pennington",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA078899"
        ],
        "brand_name": [
          "BROMOCRIPTINE MESYLATE"
        ],
        "generic_name": [
          "BROMOCRIPTINE MESYLATE"
        ],
        "manufacturer_name": [
          "Zydus Pharmaceuticals USA Inc."
        ],
        "product_ndc": [
          "68382-110"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "BROMOCRIPTINE MESYLATE"
        ],
        "rxcui": [
          "197412"
        ],
        "spl_id": [
          "b9165827-6509-4d3c-813a-547929b720da"
        ],
        "spl_set_id": [
          "d69003ee-0b6f-47a9-834e-ba59c02f566c"
        ],
        "package_ndc": [
          "68382-110-06",
          "68382-110-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "FFP983J3OD"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97847",
      "recalling_firm": "Zydus Pharmaceuticals (USA) Inc",
      "address_1": "73 Route 31 N",
      "address_2": "",
      "postal_code": "08534-3601",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0159-2026",
      "product_description": "Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals, Pennington, NJ 08534. NDC 68382-110-06",
      "product_quantity": "36,624 bottles",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.",
      "recall_initiation_date": "20251023",
      "center_classification_date": "20251119",
      "report_date": "20251126",
      "code_info": "Lot #: M313934, M313935, M315615, Exp. Date Nov 2025; M316809 , Exp. Date Dec-25; M405765, M405763, M405764, Exp. Date Apr-26; M414999, M414241, M414307, M414305, Exp. Date Oct-26",
      "more_code_info": ""
    }
  ]
}