FDA-Drug2026-03-11Class IIPROCESSING DEFECT
Harbin Jixianglong semaglutide recalled for incomplete manufacturing validation
What this means
Harbin Jixianglong Biotech distributed semaglutide (an injectable medication for compounding) without completing required manufacturing process and bacterial endotoxin testing. This means the drug may not meet safety and purity standards. The affected lot is CP-030-20250711 with an expiration date of July 24, 2027.
- If you have semaglutide from Harbin Jixianglong with lot CP-030-20250711, stop using it immediately.
- Contact your pharmacist or healthcare provider for guidance on next steps.
- Do not discard medication in the trash or toilet; ask your pharmacy how to safely dispose of it.
The agency's original wording
Hazard
CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
Intended for
Adults
Illnesses reported
None reported
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 Manufacturer: 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-0379-2026Want us to check the next one for you?
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