Recalls / Class II
Class IID-0379-2026
Product
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
- Affected lot / code info
- Lot #: CP-030-20250711, Exp. Date Jul. 24th, 2027
Why it was recalled
CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
Recalling firm
- Firm
- Harbin Jixianglong Biotech Co., Ltd.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- North Of Baoan Road, East Of Changqing Street, Hulan District, Haerbin, N/A N/A, China
Distribution
- Quantity
- N/A
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2026-02-13
- FDA classified
- 2026-03-02
- Posted by FDA
- 2026-03-11
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0379-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.