Harbin Jixianglong Biotech Co. Issues Nationwide Recall of Semaglutide Over Manufacturing Deviations
Harbin Jixianglong Biotech Co., Ltd. has voluntarily recalled specific lots of Semaglutide used for Rx compounding due to failures in process and bacterial endotoxin validation.
What Happened
Harbin Jixianglong Biotech Co., Ltd. has initiated a voluntary recall of Semaglutide drug substance intended for prescription compounding. The recall is the result of Current Good Manufacturing Practice (CGMP) deviations. Specifically, the firm failed to complete necessary process validation and bacterial endotoxin method validation before the product was distributed to the market.
Which Products Are Affected
The recall affects Semaglutide packaged for Rx compounding use only, manufactured by Harbin Jixianglong Biotech Co., Ltd. in Harbin, China. The following configurations are included in the recall:
- 1g: NDC 84385-106-01
- 5g: NDC 84385-106-02
- 10g: NDC 84385-106-06
- 25g: NDC 84385-106-03
- 50g: NDC 84385-106-04
Lot Information:
- Lot Number: CP-030-20250711
- Expiration Date: July 24, 2027
These products were distributed nationwide within the United States.
What You Should Do
Compounding pharmacies and healthcare facilities that have received the affected lot should immediately cease using the product for compounding medications. The recalling firm notified customers of the issue via email on February 13, 2026. For information regarding product returns or further guidance, stakeholders should contact Harbin Jixianglong Biotech Co., Ltd. directly.
Why This Matters
This recall is significant because the failure to validate bacterial endotoxin methods means the safety and purity of the drug substance cannot be guaranteed, potentially exposing patients to contaminated compounded medications.
Source
Information provided by the FDA under Recall Number D-0379-2026.
Source: FDA Official Notice