Harbin Jixianglong faces US import restrictions after semaglutide API recall
FDA placed Harbin Jixianglong Biotech on Import Alert 66-40 and removed it from the GLP-1 API import green list on February 27, following a recall of two semaglutide API batches distributed in the United States. A warning letter issued on May 1 subsequently documented the February actions and the manufacturing-traceability concerns behind them.
The batches, CP-030-20250711 and CP-030-20250911, had been purchased from external suppliers, repackaged and relabelled with Harbin identified as the manufacturer, according to FDA. The agency found inadequate supplier qualification, unsupported changes to manufacturing and retest dates, and incomplete records identifying the actual manufacturers. Their identities were redacted.
Import Alert 66-40 permits detention without physical examination of covered drugs from listed establishments with manufacturing-compliance deficiencies. Removal from the separate 66-80 green list ended Harbin’s listed exception for covered GLP-1 API imports. These measures were broader than the recall of the two specified lots.
The case concerns both the disposition of distributed material and subsequent import access. It does not establish that every shipment was stopped or that Harbin’s entire production was affected. The available records disclose neither affected quantities nor named US customers, leaving the scale of any wider supply interruption unresolved.
Sources
FDA warning letter, May 1, 2026 — documenting the February recall and import actions