FDA-Drug2026-03-11Class IIPROCESSING DEFECT
Harbin Jixianglong semaglutide recalled for incomplete manufacturing validation
OTHERNationwide distribution
Contact your pharmacy about semaglutide
The FDA is recalling semaglutide powder distributed by Harbin Jixianglong Biotech for compounding use only. The manufacturer did not complete required manufacturing process and bacterial endotoxin testing before shipping the product. This was a manufacturing oversight, not a confirmed safety incident.
- If you use compounded semaglutide, contact your pharmacy or prescriber to confirm whether your medication is affected.
- Do not stop taking semaglutide without talking to your doctor.
- Your pharmacy will advise you on next steps if your medication is part of this recall.
Hazard
CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
Sold states
Nationwide within the United States
Affected count
N/A
Manufactured in
North Of Baoan Road, East Of Changqing Street, Hulan District, Haerbin, N/A, China
Products
Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04; e) 100g, NDC 84385-106-05Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street, Limin Development Zone, Harbin, China.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0380-2026Don't want to check this manually?
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