The Food and Drug Administration (FDA) has classified a recall of Semaglutide, intended for Rx compounding use, distributed by Harbin Jixianglong Biotech Co., Ltd. as a Class II recall (D-0379-2026). This action is due to significant Current Good Manufacturing Practice (CGMP) deviations, including the failure to complete process validation and bacterial endotoxin method validation prior to product distribution. The affected product was distributed nationwide.

This recall signifies a critical failure in manufacturing quality control. Drug manufacturers and compounders using this product must immediately cease its use and ensure proper disposal or return procedures are followed. While the document does not specify a compliance deadline, the ongoing nature of the recall implies immediate action is required to mitigate potential patient risk. Failure to comply with recall procedures can result in further enforcement actions by the FDA.