Harbin Jixianglong Biotech Co., Ltd.

FDA Class II Recall: Harbin Jixianglong Biotech's Semaglutide API Faces Critical CGMP Violations

Harbin Jixianglong Biotech Co., Ltd. has initiated a Class II recall (D-0379-2026) for its Semaglutide API distributed nationwide in the U.S. This critical action stems from significant CGMP deviations, specifically the failure to complete process and bacterial endotoxin method validation before distribution. U.S. compounding pharmacies must immediately assess inventory and evaluate alternative sourcing strategies.