FDA 执法报告 D-0873-2026：Amneal 的 Estradiol 凝胶因包装药袋空置或未装满被列为 Class II 召回
FDA drug enforcement D-0873-2026: Amneal Pharmaceuticals, LLC — Defective Container; packets were found to be either empty or partially full.
FDA 药品执法报告 D-0873-2026 记录 Amneal Pharmaceuticals 的 Estradiol 凝胶 0.1%（NDC 69238-2452-3）被列为 Class II 召回，原因为包装缺陷，药袋被发现为空或未装满。
该执法报告记录 Estradiol 凝胶因药袋空置或未装满被列为 Class II 召回，并列出批号与全国分销范围，便于读者核对同批产品信息。
FDA drug recall enforcement report — D-0873-2026
Report issued: 2026-10-07. 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": "400 Crossing Blvd Fl 3",
"address_2": "",
"center_classification_date": "20260928",
"city": "Bridgewater",
"classification": "Class II",
"code_info": "Lot # 245226005B, Exp Date: 04/30/2028.",
"country": "United States",
"distribution_pattern": "Nationwide in the USA.",
"event_id": "99742",
"initial_firm_notification": "Letter",
"more_code_info": "",
"openfda": {
"application_number": [
"ANDA216055"
],
"brand_name": [
"ESTRADIOL"
],
"generic_name": [
"ESTRADIOL TRANSDERMAL"
],
"is_original_packager": [
true
],
"manufacturer_name": [
"Amneal Pharmaceuticals NY LLC"
],
"nui": [
"M0447348",
"N0000175825",
"N0000000100"
],
"package_ndc": [
"69238-2452-1",
"69238-2452-3",
"69238-2451-1",
"69238-2451-3",
"69238-2450-1",
"69238-2450-3",
"69238-2449-1",
"69238-2449-3",
"69238-2448-1",
"69238-2448-3"
],
"pharm_class_cs": [
"Estradiol Congeners [CS]"
],
"pharm_class_epc": [
"Estrogen [EPC]"
],
"pharm_class_moa": [
"Estrogen Receptor Agonists [MoA]"
],
"product_ndc": [
"69238-2448",
"69238-2452",
"69238-2451",
"69238-2450",
"69238-2449"
],
"product_type": [
"HUMAN PRESCRIPTION DRUG"
],
"route": [
"TOPICAL"
],
"rxcui": [
"2619677",
"2619679",
"2619681",
"2619683",
"2619685"
],
"spl_id": [
"cebb61d3-34b7-44a7-aae7-d23e21651713"
],
"spl_set_id": [
"9669a0e3-27e2-4f6c-961c-7a67e9f84cc8"
],
"substance_name": [
"ESTRADIOL"
],
"unii": [
"4TI98Z838E"
]
},
"postal_code": "08807-2863",
"product_description": "Estradiol Gel, 0.1%, 0.25 mg, 30-packets per carton, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08907, NDC 69238-2452-3.",
"product_quantity": "2,592 30-count cartons",
"product_type": "Drugs",
"reason_for_recall": "Defective Container; packets were found to be either empty or partially full.",
"recall_initiation_date": "20260908",
"recall_number": "D-0873-2026",
"recalling_firm": "Amneal Pharmaceuticals, LLC",
"report_date": "20261007",
"state": "NJ",
"status": "Ongoing",
"voluntary_mandated": "Voluntary: Firm initiated"
}
来源：openFDA 已分级药品召回执法报告 · api.fda.gov