{
  "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": "Parsippany",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA076737"
        ],
        "brand_name": [
          "TESTOSTERONE"
        ],
        "generic_name": [
          "TESTOSTERONE"
        ],
        "manufacturer_name": [
          "Actavis Pharma, Inc."
        ],
        "product_ndc": [
          "0591-2921",
          "0591-3216",
          "0591-3217"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "TESTOSTERONE"
        ],
        "rxcui": [
          "1596780",
          "1597123",
          "1597129"
        ],
        "spl_id": [
          "38f554a5-ee64-4429-96c5-52b02c7763c1"
        ],
        "spl_set_id": [
          "5834d34f-839d-412c-b74c-da1dad2cfa88"
        ],
        "package_ndc": [
          "0591-2921-18",
          "0591-2921-02",
          "0591-3216-17",
          "0591-3216-30",
          "0591-3217-26",
          "0591-3217-30"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175824",
          "N0000000146",
          "M0001109"
        ],
        "pharm_class_epc": [
          "Androgen [EPC]"
        ],
        "pharm_class_moa": [
          "Androgen Receptor Agonists [MoA]"
        ],
        "pharm_class_cs": [
          "Androstanes [CS]"
        ],
        "unii": [
          "3XMK78S47O"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97944",
      "recalling_firm": "Teva Pharmaceuticals USA, Inc",
      "address_1": "400 Interpace Pkwy Bldg A",
      "address_2": "",
      "postal_code": "07054-1120",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S. Nationwide",
      "recall_number": "D-0198-2026",
      "product_description": "Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis Laboratories, Inc, Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3216-30.  Packet label: Testosterone Gel 1%, contains 2.5 grams, For topical use only,  Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054,NDC: 0591-3216-17.",
      "product_quantity": "15,944 cartons",
      "reason_for_recall": "Defective Container - A defect in the side-seal which allows leakage of product.",
      "recall_initiation_date": "20251107",
      "center_classification_date": "20251201",
      "report_date": "20251210",
      "code_info": "Lot #100068692, Exp.: 04/30/2027",
      "more_code_info": ""
    }
  ]
}