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 for Rx compounding
- Model numbers
- Batch CP-030-20250911, Mfg Date: Sep 25, 2025, Retest Date: Sep 24, 2027, 2025, 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 for Rx compounding is used to prepare customized pharmaceutical products for patients under medical supervision.
Why This Is Dangerous
CGMP deviations and lack of validated endotoxin testing raise risk of contaminated injectable product and possible infection.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Potential endotoxin exposure could lead to severe infection in patients requiring medical treatment.
Practical Guidance
How to identify if yours is affected
- Check Lot: CP-030-20250911.
- Confirm manufacturing date: Sep 25, 2025.
- Check retest date: Sep 24, 2027.
Where to find product info
FDA enforcement recall page for D-0380-2026; recall notice details.
What timeline to expect
Not specified by the recall notice; use FDA guidance and company contact for updates.
If the manufacturer is unresponsive
- Escalate to FDA recall contact channels.
- File consumer complaint if no resolution within a reasonable time.
- Keep copies of all correspondence and recall notices.
How to prevent similar issues
- Require CGMP-compliant suppliers for compounding drugs.
- Verify endotoxin testing and batch validation before distribution.
- Keep batch numbers and NDCs for future recalls.
Documentation advice
Save recall notice, batch numbers, manufacturer contact, and medical records if exposure occurs.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Product: Semaglutide for Rx compounding use only. Packaging sizes and NDCs: 1 g (84385-106-01); 5 g (84385-106-02); 10 g (84385-106-06); 25 g (84385-106-03); 50 g (84385-106-04); 100 g (84385-106-05). Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street, Limin Development Zone, Harbin, China. Distribution: Nationwide in the United States. Recall Date: 2026-02-13. Report Date: 2026-03-11. Classification: Class II. Quantity: N/A.
Key Facts
- 6 packaging sizes recalled: 1 g, 5 g, 10 g, 25 g, 50 g, 100 g
- Mfg Date: Sep 25, 2025
- Retest Date: Sep 24, 2027
- Recall date: 2026-02-13; Report date: 2026-03-11; Status: Active
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.
