HIGH

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...

CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution

Quick Facts at a Glance

Recall Date
February 13, 2026
Hazard Level
HIGH
Brand
Harbin Jixianglong Biotech Co.
Geographic Scope
1 states

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

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Full 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; e) 100g, NDC 84385-106-05Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street, Limin Development Zone, Harbin, China.. Reason: CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution. Classification: Class II. Quantity: N/A. Distribution: Nationwide within the United States

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Product Classification

Product Details

Model Numbers
Batch # CP-030-20250911
Mfg Date: Sep. 25th
2025
Retest Date: Sep. 24th
2027.
Affected States
ALL
Report Date
March 11, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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