Semaglutide — Class II drug recall D-0380-2026
Ongoing recall by Harbin Jixianglong Biotech Co., Ltd., reported 2026-03-11, distributed nationwide. CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial end
| Recall number | D-0380-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Harbin Jixianglong Biotech Co., Ltd., Haerbin, N/A, China |
| Recall initiated | 2026-02-13 |
| Classified | 2026-03-02 |
| Reported by FDA | 2026-03-11 |
| Distributed | Nationwide (US) |
| Reason classes | microbial contamination, sterility, cgmp |
| NDC | 84385-0106-01, 84385-0106-02, 84385-0106-03, 84385-0106-04, 84385-0106-05, 84385-0106-06 |
| Lot numbers | 2025, 25TH, CP-030-20250911 |
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; e) 100g, NDC 84385-106-05Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street, Limin Development Zone, Harbin, China.
Reason for recall
CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.