United StatesSemaglutide for Rx compounding use only, packaged in 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) and 100g (NDC 84385-106-05), identified by lot CP-030-20250711 (Exp. Jul. 24, 2027) and batch CP-030-20250911 (Mfg Sep. 25, 2025; Retest Sep. 24, 2027), is being recalled. The recall by Harbin Jixianglong Biotech Co., Ltd. was initiated for CGMP deviations, specifically failing to complete process validation and bacterial endotoxin method validation before distribution.
What's being recalled
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
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.
Recalling firm: Harbin Jixianglong Biotech Co., Ltd., Haerbin, N/A, China.
How to identify it
Lot #: CP-030-20250711, Exp. Date Jul. 24th, 2027 Batch # CP-030-20250911, Mfg Date: Sep. 25th, 2025, Retest Date: Sep. 24th, 2027.
The hazard
CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Nationwide within the United States
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)