Quick Facts at a Glance
- Recall Date
- February 13, 2026
- Hazard Level
- HIGH
- Brand
- Harbin Jixianglong Biotech Co.
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Harbin Jixianglong Biotech Co.
- Product type
- Semaglutide API (Rx compounding use)
- Model numbers
- CP-030-20250711, Exp. July 24, 2027
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
February 13, 2026
Reported by FDA DRUG
March 11, 2026
RecallRadar source check
March 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Harbin Jixianglong Biotech Co., Ltd. or your healthcare provider for guidance. Notification method: E-Mail
About This Product
Semaglutide is a GLP-1 receptor agonist used for diabetes and weight management in specialty settings. In Rx compounding, it is prepared for individualized dosing by healthcare providers.
Why This Is Dangerous
The CGMP deviations suggest the product may not have undergone validated sterility and endotoxin testing, posing infection or inflammatory risk to patients.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Clinical use of contaminated or unvalidated semaglutide could lead to adverse reactions requiring medical care. There is potential disruption to patient treatment schedules.
Practical Guidance
How to identify if yours is affected
- Check lot number CP-030-20250711
- Check expiry date July 24, 2027
- Confirm packaging and labeling from your supplier
- Cease use if matching identifiers
Where to find product info
Packaging labels display NDC codes and lot numbers; recall notices and FDA enforcement pages provide identifiers.
What timeline to expect
No refunds are described; recall remains active while manufacturers address CGMP issues.
If the manufacturer is unresponsive
- Contact FDA recall hotline or submit a report via FDA recall portal
- Work with healthcare provider to determine next steps
- Consult state health department if provider is unresponsive
How to prevent similar issues
- Source from FDA-registered, CGMP-compliant manufacturers
- Verify endotoxin validation and process validation in supplier documentation
- Maintain traceability of lots and NDCs for all compounded products
Documentation advice
Retain recall notices, communications from manufacturer, packaging labels with NDCs and lot numbers, and any adverse event reports.
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Product Details
Model numbers: CP-030-20250711; NDCs: 84385-106-01, 84385-106-02, 84385-106-06, 84385-106-03, 84385-106-04. Distribution: Nationwide in the United States to healthcare providers. Sold since unknown date. Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street, Limin Development Zone, Harbin, China. Recall date: 2026-02-13. Status: ACTIVE. Expiry: July 24, 2027.
Key Facts
- Distribution: Nationwide in the United States
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Safety Guide
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