FDA 召回执法报告 D-0040-2027：Houston Rx LLC 替尔泊肽/烟酰胺注射液因无菌保证不足列为 Class II

FDA drug recall enforcement report — D-0040-2027

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": "15340 Vantage Pkwy E Ste 220",

"address_2": "",

"center_classification_date": "20261013",

"city": "Houston",

"classification": "Class II",

"code_info": "Lot# TZN-080326-20/2-2, Beyond Use Date: 12/01/2026.",

"country": "United States",

"distribution_pattern": "Nationwide in the USA.",

"event_id": "99990",

"initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",

"more_code_info": "",

"openfda": {},

"postal_code": "77032-1901",

"product_description": "Tirzepatide/Niacinamide 2mL vial (40 MG per Vial) Inj 20mg/2mg/mL, RX Only, Houston RX LLC, 15430 Vantage Parkway E STE 220, Houston, TX 77032.",

"product_quantity": "64 vials",

"product_type": "Drugs",

"reason_for_recall": "Lack of assurance of sterility.",

"recall_initiation_date": "20260925",

"recall_number": "D-0040-2027",

"recalling_firm": "Houston Rx LLC",

"report_date": "20261021",

"state": "TX",

"status": "Ongoing",

"voluntary_mandated": "Voluntary: Firm initiated"

}