Harbin Jixianglong Biotech Co. recalled semaglutide for Rx compounding use distributed nationwide to healthcare providers in the United States. The recall cites CGMP deviations and failure to complete process validation and bacterial endotoxin method validation before distribution. Healthcare providers and patients should stop using this product immediately and contact the manufacturer or their CL
CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
Consumers and healthcare providers should stop using this product immediately. Contact Harbin Jixianglong Biotech Co., Ltd. or your healthcare provider for guidance. Notification method: E-Mail
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Semaglutide is a GLP-1 receptor agonist used for diabetes and weight management in specialty settings. In Rx compounding, it is prepared for individualized dosing by healthcare providers.
The CGMP deviations suggest the product may not have undergone validated sterility and endotoxin testing, posing infection or inflammatory risk to patients.
This recall is not part of a broader industry pattern.
Clinical use of contaminated or unvalidated semaglutide could lead to adverse reactions requiring medical care. There is potential disruption to patient treatment schedules.
Packaging labels display NDC codes and lot numbers; recall notices and FDA enforcement pages provide identifiers.
No refunds are described; recall remains active while manufacturers address CGMP issues.
Retain recall notices, communications from manufacturer, packaging labels with NDCs and lot numbers, and any adverse event reports.
Model numbers: CP-030-20250711; NDCs: 84385-106-01, 84385-106-02, 84385-106-06, 84385-106-03, 84385-106-04. Distribution: Nationwide in the United States to healthcare providers. Sold since unknown date. Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street, Limin Development Zone, Harbin, China. Recall date: 2026-02-13. Status: ACTIVE. Expiry: July 24, 2027.
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