Harbin Jixianglong Biotech recalls Semaglutide for Rx compounding due to CGMP deviations and bacterial endotoxin validation failures. Affected products include 1g, 5g, 10g, 25g, and 50g doses with specific NDCs.
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 Semaglutide products for prescription compounding use only because they failed to complete critical quality tests before distribution. This could lead to bacterial contamination risks if used improperly.
The products were distributed without completing required process validation and bacterial endotoxin testing, which are critical for ensuring safety in prescription compounding. This failure could result in bacterial contamination if the products are used without proper quality controls.
Prescription compounding pharmacies and healthcare providers who purchased the affected Semaglutide products. Patients using these products through compounding pharmacies are at risk of bacterial contamination.
Check for Semaglutide products labeled as 'For Rx compounding use only' with NDC codes 84385-106-01 (1g), 84385-106-02 (5g), 84385-106-06 (10g), 84385-106-03 (25g), or 84385-106-04 (50g).
Look for the NDC codes listed above on the product packaging to confirm if it is affected.
The manufacturer failed to complete process validation and bacterial endotoxin method validation before distributing the products, which could lead to bacterial contamination risks.
The products may contain bacterial endotoxins due to incomplete quality testing, which could cause infections if used improperly.
Check for Semaglutide products labeled 'For Rx compounding use only' with NDC codes 84385-106-01, 84385-106-02, 84385-106-06, 84385-106-03, or 84385-106-04.
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-0380-2026 — Harbin Jixianglong Biotech Harbin Jixianglong Biotech Hello, I own a Harbin Jixianglong Biotech that is covered by recall D-0380-2026 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.
