Harbin Jixianglong Biotech Recalls Semaglutide for Compounding Due to CGMP Deviations
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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 consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency 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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
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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 ↗
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