75%Confidence
1Views
FDASource
2026-03-26Date
Summary
Semaglutide API recall due to incomplete validation processes highlights regulatory risks in the compounding supply chain, potentially affecting weight loss medication availability. This underscores quality concerns with Chinese API manufacturers supplying the booming GLP-1 market.
Actionable: Audit your semaglutide supply chain and verify validation documentation from all API suppliers.
AI Confidence: 75%
Data Points
firmHarbin Jixianglong Biotech Co., Ltd.
classificationClass II
statusOngoing
distributionNationwide within the United States
productSemaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-1
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