Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 8438
Summary
The FDA issued a Class II for Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b by Harbin Jixianglong Biotech Co., Ltd.. Reason: CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribu.
Details
Source
Drug Recall
External ID
D-0379-2026
Action Date
2026-03-11
Status
Ongoing
Category
drug
Product Description
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
Lot/Code Info: Lot #: CP-030-20250711, Exp. Date Jul. 24th, 2027
Quantity Affected: N/A
Reason for Recall
CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2026-02-13
Company
Haerbin, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 85 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Harbin Jixianglong Biotech Co., Ltd. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Harbin Jixianglong Biotech Co., Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Harbin Jixianglong Biotech Co., Ltd. have FDA actions?
Harbin Jixianglong Biotech Co., Ltd. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0379-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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