Recall
FDAHealthFebruary 13, 2026

Harbin Jixianglong Biotech Co., Ltd. — 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) 50

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

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
February 13, 2026

Nationwide within the United States

What's affected?

Product
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 Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street, Limin Development Zone, Harbin, China
Lot code
CP-030-20250711

Additional details

Lot #: CP-030-20250711, Exp. Date Jul. 24th, 2027

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: N/A.

View original FDA notice →

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