{
  "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": "Chestnut Ridge",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA076744"
        ],
        "brand_name": [
          "TESTOSTERONE"
        ],
        "generic_name": [
          "TESTOSTERONE"
        ],
        "manufacturer_name": [
          "Strides Pharma Science Limited"
        ],
        "product_ndc": [
          "64380-151",
          "64380-152"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TRANSDERMAL"
        ],
        "substance_name": [
          "TESTOSTERONE"
        ],
        "rxcui": [
          "1597123",
          "1597129"
        ],
        "spl_id": [
          "6d50f17e-4607-458a-882b-620daa3b58a9"
        ],
        "spl_set_id": [
          "ee54c393-bcfe-4a52-b7b3-1da8750f35d9"
        ],
        "package_ndc": [
          "64380-152-01",
          "64380-152-02",
          "64380-151-01",
          "64380-151-02"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0364380151012",
          "0364380152019"
        ],
        "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": "96412",
      "recalling_firm": "Strides Pharma, Inc.",
      "address_1": "1 Ram Ridge Rd",
      "address_2": "N/A",
      "postal_code": "10977-6714",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the U.S",
      "recall_number": "D-0294-2025",
      "product_description": "Testosterone Gel 1%, 5 grams, 30 Unit-dose Packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-152-02",
      "product_quantity": "244,412 Cartons; 30 sachets /Carton",
      "reason_for_recall": "Presence of foreign substance: Presence of Benzene.",
      "recall_initiation_date": "20250305",
      "center_classification_date": "20250325",
      "report_date": "20250402",
      "code_info": "Lot #: 5501103A, Exp Mar-25; 5501237A, 5501238A, Exp Apr-25; 5501278A, Exp May-25; 5501280A, 5501342A, Exp Jun-25; 5501372A, Exp Jul-25; 5501496A, Exp Aug-25; 5501499A, Exp Sep-25; 5501580A, Exp Oct-25; 5501582A, Exp Dec-25; 5501653A, 5501656A, Exp Jan-26; 5501770A, Exp Feb-26; 5501842A, 5501868A, 5501882A, Exp Apr-26; 5501957A, Exp May-26; 5502001A, Exp Jul-26; 5502033A, Exp Aug-26; 5502112A, 5502115A, Exp Oct-26; 5502180A, 5502181A, Exp Nov-26."
    }
  ]
}