The Recall Desk

FDA (Drugs) recall action 98438

Harbin Jixianglong Biotech Co., Ltd. recalled 2 products on 2026-03-11

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2026-03-11
Critical
0
Units
—

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

1–2 of 2

  • ModerateFDA (Drugs)··2026-03-11

    Semaglutide compounding ingredient recalled over incomplete process and endotoxin validation

    Harbin Jixianglong Biotech is recalling Semaglutide for prescription compounding use because process validation and bacterial endotoxin method validation were not completed before distribution.

    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; e) 100g, NDC 84385-106-05Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road,
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2026-03-11

    Semaglutide compounding ingredient lot recalled over incomplete validation before distribution

    Harbin Jixianglong Biotech is recalling a further lot of Semaglutide for prescription compounding because process validation and bacterial endotoxin method validation were not completed before distribution.

    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,
    Category
    Distribution
    0 states