Semaglutide recalled over manufacturing violations

Recall date

February 13, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Harbin Jixianglong Biotech Co., Ltd. recalls Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 843…

Recall number

D-0380-2026

FDA classification

Class II

Brand / firm

Harbin Jixianglong Biotech Co., Ltd.

Sold / distributed

Nationwide within the United States

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.