{
  "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": "Bridgewater",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "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": "97438",
      "recalling_firm": "Amneal Pharmaceuticals, LLC",
      "address_1": "400 Crossing Blvd Fl 3",
      "address_2": "N/A",
      "postal_code": "08807-2863",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distributed Nationwide in the USA",
      "recall_number": "D-0615-2025",
      "product_description": "Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx Only, Packaged as a) 100-count bottle, NDC 65162-272-10; b) 500-count bottle, NDC  65162-272-50; Manufactured by: Amneal Pharmaceuticals, Pvt. Ltd, Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807.",
      "product_quantity": "60,072 100-count, 73,054 500-count bottles",
      "reason_for_recall": "Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was   detected with presence of a micro-organism. No micro-organism was detected on any tablets.",
      "recall_initiation_date": "20250818",
      "center_classification_date": "20250904",
      "report_date": "20250910",
      "code_info": "Lot a) AM240173, Exp Date 01/31/2027, AM240680, Exp Date 05/31/2027, AM 240921, Exp Date 06/30/2027, AM241191, Exp Date 08/31/2027.  Lot b) AM240176, AM240177, Exp Date 01/31/2027, AM240301, AM240300, Exp Date 02/28/2027, AM240676, AM240677, Exp Date 04/30/2027, AM240678, AM240679, Exp Date 05/30/2027. AM240922, AM240923, AM240924, AM240925, Exp Date 6/30/27, AM241086, Exp Date 7/31/27, AM241087, AM241088, Exp Date 8/31/27."
    }
  ]
}