{
  "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 II",
      "openfda": {
        "application_number": [
          "ANDA209755"
        ],
        "brand_name": [
          "CHLORPROMAZINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "CHLORPROMAZINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Amneal Pharmaceuticals NY LLC"
        ],
        "product_ndc": [
          "69238-1054",
          "69238-1056",
          "69238-1058",
          "69238-1060",
          "69238-1062"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CHLORPROMAZINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "991039",
          "991044",
          "991188",
          "991194",
          "991336"
        ],
        "spl_id": [
          "964b7e58-d444-4f06-91e2-82dbb7b56191"
        ],
        "spl_set_id": [
          "aa086a21-de85-4b03-af58-49b70acf8cf0"
        ],
        "package_ndc": [
          "69238-1054-1",
          "69238-1056-1",
          "69238-1058-1",
          "69238-1060-1",
          "69238-1062-1"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0369238105612",
          "0369238106213"
        ],
        "unii": [
          "9WP59609J6"
        ]
      },
      "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-0617-2025",
      "product_description": "chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1058-1.",
      "product_quantity": "13,130 100-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: AM240147, AM240148, Exp Date 01/31/2027; Lot AM240664,  AM240665, Exp Date 04/30/2027."
    }
  ]
}