FDA Drug recall D-0379-2026
Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01
- FDA Drug
- Class II
- ongoing
- Published 2026-03-11
On 2026-03-11 the FDA classified a Class II recall of Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01 by Harbin Jixianglong Biotech, citing CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0379-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-02-13 |
| Published | 2026-03-11 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Harbin Jixianglong Biotech |
| Distribution | US |
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
Reason
CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
Identifiers
| code_info | Lot #: CP-030-20250711, Exp. Date Jul. 24th, 2027 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0379-2026%22
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