{
  "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": "Bridgewater",
      "state": "NJ",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "ANDA076899"
        ],
        "brand_name": [
          "SULFAMETHOXAZOLE AND TRIMETHOPRIM"
        ],
        "generic_name": [
          "SULFAMETHOXAZOLE AND TRIMETHOPRIM"
        ],
        "manufacturer_name": [
          "Amneal Pharmaceuticals LLC"
        ],
        "product_ndc": [
          "65162-271",
          "65162-272"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SULFAMETHOXAZOLE",
          "TRIMETHOPRIM"
        ],
        "rxcui": [
          "198334",
          "198335"
        ],
        "spl_id": [
          "fd58f01a-3607-4f18-97e3-f695bcb32ad5"
        ],
        "spl_set_id": [
          "f0e73842-6002-43c2-97fc-0cadc1bf6346"
        ],
        "package_ndc": [
          "65162-271-05",
          "65162-271-10",
          "65162-271-50",
          "65162-271-11",
          "65162-272-01",
          "65162-272-24",
          "65162-272-10",
          "65162-272-25",
          "65162-272-50"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0365168211102",
          "0365162272109"
        ],
        "nui": [
          "N0000175489",
          "N0000000191",
          "N0000187062",
          "N0000187061",
          "N0000175504",
          "M0020790",
          "N0000185504"
        ],
        "pharm_class_epc": [
          "Dihydrofolate Reductase Inhibitor Antibacterial [EPC]",
          "Sulfonamide Antimicrobial [EPC]"
        ],
        "pharm_class_moa": [
          "Dihydrofolate Reductase Inhibitors [MoA]",
          "Cytochrome P450 2C8 Inhibitors [MoA]",
          "Organic Cation Transporter 2 Inhibitors [MoA]",
          "Cytochrome P450 2C9 Inhibitors [MoA]"
        ],
        "pharm_class_cs": [
          "Sulfonamides [CS]"
        ],
        "unii": [
          "AN164J8Y0X",
          "JE42381TNV"
        ]
      },
      "product_type": "Drugs",
      "event_id": "96985",
      "recalling_firm": "Amneal Pharmaceuticals, LLC",
      "address_1": "400 Crossing Blvd Fl 3",
      "address_2": "",
      "postal_code": "08807-2863",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Press Release",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0488-2025",
      "product_description": "Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b) 500 Tablets per Bottle, NDC: 65162-271-50, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807.",
      "product_quantity": "6396 bottles",
      "reason_for_recall": "Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.",
      "recall_initiation_date": "20250602",
      "center_classification_date": "20250623",
      "report_date": "20250618",
      "code_info": "Lot #s: a) AM241019, AM241020, Exp. 06/30/2027 b) AM241019A, Exp 06/30/2027",
      "more_code_info": ""
    }
  ]
}