FDA 执法报告 D-0038-2027：Teva 甲氧氯普胺片因存在外源片剂/胶囊被列为 II 类召回
FDA drug enforcement D-0038-2027: Teva Pharmaceuticals USA, Inc — Presence of Foreign Tablets/Capsules
FDA 执法报告 D-0038-2027 将 Teva Pharmaceuticals USA 的甲氧氯普胺片 5 mg 列为 II 类召回，原因为存在外源片剂/胶囊。
该执法报告记录列出甲氧氯普胺片的召回等级、受影响批号与全美分销范围，便于核对本次召回的覆盖边界。
FDA drug recall enforcement report — D-0038-2027
Report issued: 2026-10-21. 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 Interpace Pkwy Bldg A",
"address_2": "",
"center_classification_date": "20261013",
"city": "Parsippany",
"classification": "Class II",
"code_info": "Lot, expiry: [100 Tablets] Lots 8634085, 8635085, 8636085, exp 07/2027; [500 Tablets] Lot 8633085, exp 07/2027",
"country": "United States",
"distribution_pattern": "US Nationwide.",
"event_id": "100013",
"initial_firm_notification": "Letter",
"more_code_info": "",
"openfda": {
"application_number": [
"ANDA070184"
],
"brand_name": [
"METOCLOPRAMIDE"
],
"generic_name": [
"METOCLOPRAMIDE"
],
"is_original_packager": [
true
],
"manufacturer_name": [
"Teva Pharmaceuticals USA, Inc."
],
"package_ndc": [
"0093-2204-01",
"0093-2204-05",
"0093-2203-01",
"0093-2203-05",
"0093-2203-10"
],
"product_ndc": [
"0093-2203",
"0093-2204"
],
"product_type": [
"HUMAN PRESCRIPTION DRUG"
],
"route": [
"ORAL"
],
"rxcui": [
"311666",
"311668"
],
"spl_id": [
"61b5d2d5-1e7b-44ff-a831-1a0de78edecd"
],
"spl_set_id": [
"e15905e0-e0f6-4c8b-ac19-59724d6c4bf0"
],
"substance_name": [
"METOCLOPRAMIDE HYDROCHLORIDE"
],
"unii": [
"W1792A2RVD"
],
"upc": [
"0300932203013",
"0300932204010"
]
},
"postal_code": "07054-1120",
"product_description": "Metoclopramide Tablets, USP, 5 mg, [100 or 500] Tablets per bottle, Rx Only, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC 100 Tablets: 0093-2204-01; NDC 500 Tablets: 0093-2204-05",
"product_quantity": "240,448 cartons",
"product_type": "Drugs",
"reason_for_recall": "Presence of Foreign Tablets/Capsules",
"recall_initiation_date": "20260929",
"recall_number": "D-0038-2027",
"recalling_firm": "Teva Pharmaceuticals USA, Inc",
"report_date": "20261021",
"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