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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Harbin Jixianglong Semaglutide Recalled for Process Validation Failures

Agency Publication Date: March 2, 2026
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Summary

Harbin Jixianglong Biotech Co., Ltd. has issued a voluntary recall for several lots of Semaglutide intended for prescription compounding. The recall was initiated because the manufacturer failed to complete necessary process validation and bacterial endotoxin testing before distributing the product. These products are sold in various sizes ranging from 1 gram to 100 grams for use by compounding pharmacies.

Risk

The lack of proper bacterial endotoxin validation means the product may contain harmful impurities that could cause severe inflammatory responses or infections when the drug is compounded and administered to patients.

What You Should Do

  1. Check your supply for Semaglutide packaged in 1g, 5g, 10g, 25g, 50g, or 100g containers with NDC numbers 84385-106-01, 84385-106-02, 84385-106-06, 84385-106-03, 84385-106-04, or 84385-106-05.
  2. Identify if you have lot numbers CP-030-20250711 (Exp. July 24, 2027) or CP-030-20250911 (Retest Date Sept. 24, 2027).
  3. Stop using the recalled product immediately. Contact Harbin Jixianglong Biotech Co., Ltd. or your distributor to arrange for the return of any remaining inventory.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions or to report adverse events.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Semaglutide (1g, 5g, 10g, 25g, 50g)
Variants: For Rx compounding use only
Lot Numbers:
CP-030-20250711 (Exp. Jul. 24th, 2027)
NDC:
84385-106-01
84385-106-02
84385-106-06
84385-106-03
84385-106-04

Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street, Limin Development Zone, Harbin, China | Recall #: D-0379-2026

Product: Semaglutide (1g, 5g, 10g, 25g, 50g, 100g)
Variants: For Rx compounding use only
Lot Numbers:
CP-030-20250911 (Retest Date: Sep. 24th, 2027)
NDC:
84385-106-01
84385-106-02
84385-106-06
84385-106-03
84385-106-04
84385-106-05
Date Ranges: Manufacturing Date: Sep. 25th, 2025

Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street, Limin Development Zone, Harbin, China | Recall #: D-0380-2026

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98438
Status: Active
Manufacturer: Harbin Jixianglong Biotech Co., Ltd.
Sold By: Compounding pharmacies; Wholesalers
Manufactured In: China
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.