FDA 执法报告 D-0712-2026：Ascend Laboratories 的氨氯地平与奥美沙坦酯片因溶出度不合格及奥美沙坦酯含量低于标准被列为 Class II 召回
FDA drug enforcement D-0712-2026: Ascend Laboratories, LLC — Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
FDA 于 2026 年 7 月 29 日发布的药品召回执法报告 D-0712-2026 收录了 Ascend Laboratories, LLC 对氨氯地平与奥美沙坦酯片（10 mg/20 mg）的 Class II 自愿召回，涉及批号 25121311（有效期 2028 年 3 月 31 日），共 6,192 瓶，在全美分销。
记录列出该批氨氯地平与奥美沙坦酯片的召回分级、批号和全美分销范围，可用于核对执法报告条目。
FDA drug recall enforcement report — D-0712-2026
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": "135 Us Highway 202 206 Ste 15",
"address_2": "N/A",
"center_classification_date": "20260720",
"city": "Bedminster",
"classification": "Class II",
"code_info": "Lot 25121311, expiry 3/31/2028",
"country": "United States",
"distribution_pattern": "Nationwide in the USA",
"event_id": "99385",
"initial_firm_notification": "Letter",
"openfda": {
"application_number": [
"ANDA209042"
],
"brand_name": [
"AMLODIPINE AND OLMESARTAN MEDOXOMIL"
],
"generic_name": [
"AMLODIPINE AND OLMESARTAN MEDOXOMIL"
],
"is_original_packager": [
true
],
"manufacturer_name": [
"Ascend Laboratories, LLC"
],
"package_ndc": [
"67877-499-30",
"67877-499-90",
"67877-500-30",
"67877-500-90",
"67877-501-30",
"67877-501-90",
"67877-502-30",
"67877-502-90"
],
"product_ndc": [
"67877-499",
"67877-500",
"67877-501",
"67877-502"
],
"product_type": [
"HUMAN PRESCRIPTION DRUG"
],
"route": [
"ORAL"
],
"rxcui": [
"730861",
"730866",
"730869",
"730872"
],
"spl_id": [
"32238052-6c4c-4b29-a59e-524c819c69f1"
],
"spl_set_id": [
"c1204fbe-d086-43cf-bbaa-efec9cd0487c"
],
"substance_name": [
"AMLODIPINE BESYLATE",
"OLMESARTAN MEDOXOMIL"
],
"unii": [
"864V2Q084H",
"6M97XTV3HD"
]
},
"postal_code": "07921-2608",
"product_description": "Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC., Parsnippany, NJ 07054. NDC: 67877-500-30",
"product_quantity": "6,192 bottles",
"product_type": "Drugs",
"reason_for_recall": "Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications",
"recall_initiation_date": "20260708",
"recall_number": "D-0712-2026",
"recalling_firm": "Ascend Laboratories, LLC",
"report_date": "20260729",
"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