{
  "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": "Indianapolis",
      "state": "IN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA076899"
        ],
        "brand_name": [
          "SULFAMETHOXAZOLE AND TRIMETHOPRIM"
        ],
        "generic_name": [
          "SULFAMETHOXAZOLE AND TRIMETHOPRIM"
        ],
        "manufacturer_name": [
          "Northwind Health Company, LLC"
        ],
        "product_ndc": [
          "51655-307"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SULFAMETHOXAZOLE",
          "TRIMETHOPRIM"
        ],
        "rxcui": [
          "198335"
        ],
        "spl_id": [
          "49044499-64e8-96bd-e063-6294a90a4515"
        ],
        "spl_set_id": [
          "f2b8e9d9-1274-22ca-e053-2a95a90a6f1a"
        ],
        "package_ndc": [
          "51655-307-20",
          "51655-307-29",
          "51655-307-53",
          "51655-307-84",
          "51655-307-87"
        ],
        "original_packager_product_ndc": [
          "65162-272"
        ],
        "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": "97544",
      "recalling_firm": "Northwind Pharmaceuticals LLC",
      "address_1": "4838 Fletcher Ave Ste 1000",
      "address_2": "N/A",
      "postal_code": "46203-1642",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0654-2025",
      "product_description": "Sulfamethoxazole and Trimethoprim Tablets, USP 800mg / 160mg Double Strength packaged in a) 6-count bottles (NDC 51655-307-87), b) 10-count bottles (NDC 51655-307-53), c) 14-count bottles (NDC 51655-307-84), d) 20-count bottles (NDC 51655-307-20) Rx Only, Repackaged from Amneal Pharmaceuticals LLC. Repackaged by: Northwind Pharmaceuticals, Indianapolis, IN 46203.",
      "product_quantity": "a) 96 bottles, b) 627 bottles, c) 428 bottles, d) 1144 bottles",
      "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": "20250820",
      "center_classification_date": "20250917",
      "report_date": "20250924",
      "code_info": "Lot #: a) F118062503, Exp Date 05/31/2027, F118062507, Exp Date. 07/31/2027. b) F118062504, F118062505, Exp. Date 05/31/2027; F118062509, Exp. Date. 08/31/2027; F118062512, Exp. Date 04/30/2027. c) F118062506, Exp. Date 06/30/2027. d) F118062423, Exp. Date 01/31/2027; F118062501, Exp. Date 06/30/2027; F118062502, Exp. Date 04/30/2027; F118062508, Exp. Date 08/31/2027."
    }
  ]
}