FDAFDA · Food and drugs·Recall number D-0380-2026
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.
Published March 11, 2026 · Recall initiated: February 13, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Harbin Jixianglong Biotech Co., Ltd.
- Distributor
- Nationwide within the United States
- Lot
- Batch # CP-030-20250911, Mfg Date: Sep. 25th, 2025, Retest Date: Sep. 24th, 2027.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- China
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