FDA 药品召回执法报告 D-0729-2026：Fresenius Kabi 的 Xylocaine 注射液因产品中发现毛发被定为 II 级召回
FDA drug enforcement D-0729-2026: Fresenius Kabi USA, LLC — Presence of Particulate Matter: Hair was found in products
FDA 药品召回执法报告 D-0729-2026 显示，Fresenius Kabi USA 的 Xylocaine（利多卡因盐酸注射液，USP）1%、50 mL 多剂量瓶被定为 II 级召回，原因为存在颗粒物，产品中发现毛发。
记录给出该批无菌注射液异物召回的分类等级、批号与分销范围，可作为颗粒物污染召回案例的核对样本。
FDA drug recall enforcement report — D-0729-2026
Report issued: 2026-07-29. This is the enforcement report date, not the recall initiation date.
Scope: one classified drug product recall record; event_id may group multiple products. Unclassified records without recall numbers are outside this stream. This record is not a press release or a new enforcement finding.
The openFDA dataset is updated weekly. Report status is not a live recall status and must not be used to track the recall lifecycle. Other dates below retain their named meanings.
Complete official product record (including openFDA harmonized identifiers):
{
"address_1": "3 Corporate Dr",
"address_2": "N/A",
"center_classification_date": "20260723",
"city": "Lake Zurich",
"classification": "Class II",
"code_info": "Lot #: 6133986, Exp. Date 02/2029",
"country": "United States",
"distribution_pattern": "Nationwide within in the USA",
"event_id": "99449",
"initial_firm_notification": "Letter",
"openfda": {
"application_number": [
"NDA006488"
],
"brand_name": [
"XYLOCAINE"
],
"generic_name": [
"LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE"
],
"is_original_packager": [
true
],
"manufacturer_name": [
"Fresenius Kabi USA, LLC"
],
"package_ndc": [
"63323-492-04",
"63323-492-27",
"63323-492-09",
"63323-492-57",
"63323-492-07",
"63323-492-37",
"63323-492-03",
"63323-492-31",
"63323-491-01",
"63323-491-57",
"63323-495-09",
"63323-495-27",
"63323-495-04",
"63323-495-07",
"63323-485-01",
"63323-485-27",
"63323-485-03",
"63323-485-57",
"63323-486-01",
"63323-486-17",
"63323-486-02",
"63323-486-27",
"63323-486-05",
"63323-486-57",
"63323-484-57",
"63323-489-02",
"63323-489-27",
"63323-489-03",
"63323-489-21",
"63323-489-01",
"63323-489-17",
"63323-488-07",
"63323-488-37",
"63323-488-03",
"63323-488-31",
"63323-488-01",
"63323-488-17",
"63323-481-01",
"63323-481-57",
"63323-483-03",
"63323-483-27",
"63323-483-01",
"63323-483-57",
"63323-482-01",
"63323-482-17",
"63323-482-03",
"63323-482-27",
"63323-482-05",
"63323-482-57",
"63323-487-01",
"63323-487-17",
"63323-487-07",
"63323-487-37",
"63323-487-03",
"63323-487-31"
],
"product_ndc": [
"63323-481",
"63323-492",
"63323-491",
"63323-495",
"63323-485",
"63323-486",
"63323-484",
"63323-489",
"63323-488",
"63323-483",
"63323-482",
"63323-487"
],
"product_type": [
"HUMAN PRESCRIPTION DRUG"
],
"route": [
"INFILTRATION",
"PERINEURAL"
],
"rxcui": [
"1010033",
"1010035",
"1010671",
"1010673",
"1010688",
"1010692",
"1010745",
"1010749",
"1010751",
"1010755",
"1010759",
"1010763",
"1010900",
"1010902",
"1737343",
"1737345",
"1737562",
"1737563",
"1737566",
"1737567",
"1737568",
"1737569",
"1737570",
"1737571",
"1737757",
"1737758",
"1737761",
"1737762",
"1867938",
"1867940",
"1867943",
"1867944",
"1867992",
"1867993",
"1867996",
"1867997",
"1868028",
"1868029"
],
"spl_id": [
"ea480a68-5927-4278-9deb-2956961da428"
],
"spl_set_id": [
"ba082c2f-64f4-419d-9c88-74f203316e17"
],
"substance_name": [
"LIDOCAINE HYDROCHLORIDE ANHYDROUS",
"EPINEPHRINE BITARTRATE"
],
"unii": [
"30Q7KI53AK",
"EC2CNF7XFP"
],
"upc": [
"0363323484576",
"0363323485016",
"0363323483036",
"0363323487072",
"0363323486013",
"0363323495091",
"0363323488079",
"0363323489021",
"0363323495046",
"0363323491017",
"0363323492045",
"0363323492090",
"0363323482015",
"0363323481018"
]
},
"postal_code": "60047-8930",
"product_description": "Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25 Multiple-Dose Vials, 50 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-57; NDC Vial: 63323-485-03",
"product_quantity": "37,250 vials",
"product_type": "Drugs",
"reason_for_recall": "Presence of Particulate Matter: Hair was found in products",
"recall_initiation_date": "20260716",
"recall_number": "D-0729-2026",
"recalling_firm": "Fresenius Kabi USA, LLC",
"report_date": "20260729",
"state": "IL",
"status": "Ongoing",
"voluntary_mandated": "Voluntary: Firm initiated"
}
来源：openFDA 已分级药品召回执法报告 · api.fda.gov