Harbin Jixianglong Biotech recalls specific Semaglutide doses due to incomplete process validation and bacterial endotoxin testing before distribution. This affects prescription compounding products with NDC codes 84385-106-01 to 84385-106-06.
CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
Harbin Jixianglong Biotech is recalling certain Semaglutide doses intended for prescription compounding because their manufacturing process validation was incomplete. This could lead to unsafe products if used without proper quality checks.
The recall was initiated because the manufacturer failed to complete necessary process validation and bacterial endotoxin testing before distributing the product. This means the product may not meet safety standards for prescription compounding use.
Prescription compounding pharmacies and healthcare providers who use these specific Semaglutide doses. Those handling the recalled products without proper validation are at risk.
Check for Semaglutide doses labeled as 1g (NDC 84385-106-01), 5g (NDC 84385-106-02), 10g (NDC 84385-106-06), 25g (NDC 84385-106-03), or 50g (NDC 84385-106-04) from Harbin Jixianglong Biotech.
Look for the NDC codes 84385-106-01 to 84385-106-06 on the Semaglutide packaging.
The manufacturer failed to complete process validation and bacterial endotoxin testing before distributing the product, which could affect safety for prescription compounding.
The recall record does not specify a remedy, so contact the manufacturer directly for guidance.
The recall indicates potential safety risks due to incomplete validation, so it is not recommended for use without proper quality checks.
We’ve drafted a message you can send Harbin Jixianglong Biotech to request your refund or repair — edit it as you like.
Subject: Recall D-0379-2026 — Harbin Jixianglong Biotech Harbin Jixianglong Biotech Hello, I own a Harbin Jixianglong Biotech that is covered by recall D-0379-2026 from Harbin Jixianglong Biotech. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
