FDA Class II Drug Recall - Semaglutide

FDA: Drug Recalls Class II

Filed March 11th, 2026

Detected March 23rd, 2026

Summary

The FDA has announced a Class II drug recall initiated voluntarily by Harbin Jixianglong Biotech Co., Ltd. of China for Semaglutide intended for compounding use. The recall is due to CGMP deviations, specifically failing to complete process validation and bacterial endotoxin method validation before distribution.

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What changed

The U.S. Food and Drug Administration (FDA) has classified a voluntary recall initiated by Harbin Jixianglong Biotech Co., Ltd. of China as a Class II recall. The product affected is Semaglutide, packaged in various quantities (1g to 100g) and intended for prescription compounding use only. The recall stems from significant Current Good Manufacturing Practice (CGMP) deviations, including the failure to complete process validation and bacterial endotoxin method validation prior to the product's distribution.

This recall impacts the nationwide distribution within the United States. Companies that have received this Semaglutide product should immediately review their inventory and segregate affected batches. While the recall is voluntary, the underlying CGMP deviations indicate a potential risk to product quality and patient safety. Compliance officers should ensure proper procedures are in place for receiving and handling compounded ingredients, and verify the quality and validation status of all raw materials used in pharmaceutical preparations.

What to do next

Review inventory for affected Semaglutide batches (Batch # CP-030-20250911).
Segregate and quarantine any identified affected product.
Verify validation status of all raw materials used in compounding.

Source document (simplified)

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