{
  "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": "La Vergne",
      "state": "TN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA076899"
        ],
        "brand_name": [
          "SULFAMETHOXAZOLE AND TRIMETHOPRIM"
        ],
        "generic_name": [
          "SULFAMETHOXAZOLE AND TRIMETHOPRIM"
        ],
        "manufacturer_name": [
          "Cardinal Health 107, LLC",
          "Major Pharmaceuticals"
        ],
        "product_ndc": [
          "55154-7895",
          "0904-2725"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SULFAMETHOXAZOLE",
          "TRIMETHOPRIM"
        ],
        "rxcui": [
          "198335"
        ],
        "spl_id": [
          "c13ff702-7c1e-433d-9b59-f2c6929842c9",
          "9a4352b9-fe91-4c7b-b066-533be5c840f1"
        ],
        "spl_set_id": [
          "5dc03027-cdaf-461f-87fd-630d382fc723",
          "abe0d2d5-4879-4b4e-9b57-47ea83a17ba0"
        ],
        "package_ndc": [
          "55154-7895-0",
          "0904-2725-61"
        ],
        "original_packager_product_ndc": [
          "0904-2725",
          "65162-272"
        ],
        "upc": [
          "0055154789509"
        ],
        "nui": [
          "N0000175504",
          "M0020790",
          "N0000185504",
          "N0000175489",
          "N0000000191",
          "N0000187062",
          "N0000187061"
        ],
        "pharm_class_epc": [
          "Sulfonamide Antimicrobial [EPC]",
          "Dihydrofolate Reductase Inhibitor Antibacterial [EPC]"
        ],
        "pharm_class_cs": [
          "Sulfonamides [CS]"
        ],
        "pharm_class_moa": [
          "Cytochrome P450 2C9 Inhibitors [MoA]",
          "Dihydrofolate Reductase Inhibitors [MoA]",
          "Cytochrome P450 2C8 Inhibitors [MoA]",
          "Organic Cation Transporter 2 Inhibitors [MoA]"
        ],
        "unii": [
          "JE42381TNV",
          "AN164J8Y0X"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97523",
      "recalling_firm": "The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories",
      "address_1": "341 Mason Rd",
      "address_2": "N/A",
      "postal_code": "37086-3606",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "USA Nationwide.",
      "recall_number": "D-0625-2025",
      "product_description": "Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 10 Tablets unit dose blister pack (10x1) per bag, Rx only, Distributed by Cardinal Health, Dublin, OH 43017, NDC 55154-7895-0 (Outer Bag) containing NDC 0904-2725-61 (Inner blisters).",
      "product_quantity": "N/A",
      "reason_for_recall": "Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.",
      "recall_initiation_date": "20250902",
      "center_classification_date": "20250910",
      "report_date": "20250917",
      "code_info": "Bag: N02309A and N02309B, Exp Date: 03/31/2027; Inner blister: Lot # N02309, Exp Date: 03/31/2027"
    }
  ]
}