{
  "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": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA090509"
        ],
        "brand_name": [
          "TACROLIMUS"
        ],
        "generic_name": [
          "TACROLIMUS"
        ],
        "manufacturer_name": [
          "Dr. Reddy's Laboratories Limited"
        ],
        "product_ndc": [
          "55111-525",
          "55111-526",
          "55111-527"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "TACROLIMUS"
        ],
        "rxcui": [
          "198377",
          "198378",
          "313190"
        ],
        "spl_id": [
          "706bafff-d629-291c-5ce5-83d74a638860"
        ],
        "spl_set_id": [
          "61dee012-43af-0e9a-3843-9b9b91e022c4"
        ],
        "package_ndc": [
          "55111-525-30",
          "55111-525-01",
          "55111-525-05",
          "55111-525-79",
          "55111-525-78",
          "55111-526-30",
          "55111-526-01",
          "55111-526-05",
          "55111-526-79",
          "55111-526-78",
          "55111-527-30",
          "55111-527-01",
          "55111-527-05",
          "55111-527-79",
          "55111-527-78"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0355111527015",
          "0355111525011",
          "0355111526018"
        ],
        "unii": [
          "WM0HAQ4WNM"
        ]
      },
      "product_type": "Drugs",
      "event_id": "91661",
      "recalling_firm": "Dr. Reddy's Laboratories, Inc.",
      "address_1": "107 College Rd E",
      "address_2": "N/A",
      "postal_code": "08540-6623",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0330-2023",
      "product_description": "Tacrolimus Capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Mfd. by Dr. Reddy's Laboratories Limited, Bachupally - 500 090, INDIA; NDC 55111-525-01.",
      "product_quantity": "4,320 bottles",
      "reason_for_recall": "Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg capsules.",
      "recall_initiation_date": "20230208",
      "center_classification_date": "20230221",
      "report_date": "20230301",
      "code_info": "Lot # C2106445; Exp. 03/2024"
    }
  ]
}