Harbin Jixianglong Biotech Co. Issues Nationwide Recall of Semaglutide Over Manufacturing Deviations

Source: FDA · United States

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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 this FDA recall tells you, and what most readers miss

This notice was issued by FDA on April 2, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

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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.

Original source: FDA Official Notice ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
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.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.