Harbin Jixianglong Biotech Recalls Semaglutide for Compounding Due to CGMP Deviations
Harbin Jixianglong Biotech Co., Ltd. has voluntarily recalled several sizes 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 intended for prescription compounding use. The recall was triggered by 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, under Batch # CP-030-20250911 (Manufacturing Date: September 25, 2025; Retest Date: September 24, 2027). The product was distributed nationwide within the United States in the following configurations:
- 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
- 100g: NDC 84385-106-05
What You Should Do
Compounding pharmacies and healthcare facilities in possession of the affected batch should immediately cease use of the product. Harbin Jixianglong Biotech Co., Ltd. initially notified customers of the issue via e-mail. For information regarding returns or further instructions, stakeholders should contact the recalling firm directly at their headquarters in Harbin, China.
Why This Matters
This Class II recall highlights a significant safety concern, as the lack of bacterial endotoxin method validation poses a potential health risk to patients who receive compounded medications derived from these materials.
Source
Information provided by the U.S. Food and Drug Administration (FDA). Recall Number: D-0380-2026; Event ID: 98438.
Source: FDA Official Notice