Harbin Jixianglong Biotech Recalls Semaglutide for Compounding Due to CGMP Deviations

Source: FDA · United States

According to the U.S. Census Bureau's American Community Survey (ACS) 5-year estimates, the CDC PLACES population-level health analysis, and the CMS Hospital Compare quality data, Areazine publishes editorial articles drawing on more than 19,000 U.S. city profiles. See our methodology for full source attribution and refresh cadence.

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 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 "high" 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.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, fda, drugs) map to related alerts in the same area of risk — browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

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.

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 several sizes 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 "high" severity. Take precautions and monitor for updates.
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.