FDA recall, , Moderate risk
Harbin Jixianglong Biotech Semaglutide
Harbin Jixianglong Biotech Semaglutide failed to complete process validation and bacterial endotoxin method validation before distribution.
Summary by Recall Canary from the FDA notice
What happened
Harbin Jixianglong Biotech Co., Ltd., located in Haerbin, China, initiated a recall of Semaglutide For Rx compounding use only on February 13, 2026. The recall was added to the FDA's Enforcement Report on March 2, 2026, and was classified by the FDA on the same date. The product was distributed nationwide within the United States. The recall was initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the list below, then check the codes the FDA notice also names.
A UPC is the number printed under a barcode.
Semaglutide, For Rx compounding use only
- UPC
- 20250911
- Lot code
- CP-030-20250911
- UPC
- 20250711
- Lot code
- CP-030-20250711
From the FDA notice
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.
Recall details
- Company began the recall
- Sold in
Nationwide within the United States
- Company
- Harbin Jixianglong Biotech Co., Ltd.Haerbin, China
- Hazard
- Manufacturing problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98438
- Recall numbers
- D-0379-2026 to D-0380-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
