Semaglutide

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

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

Cause type: Microbial contamination

Bacteria, mold, yeast or other microorganisms detected in the product. Contamination can occur from water systems, equipment or handling, and can cause infection. All microbial contamination recalls.

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 Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street, Limin Development Zone, Harbin, China

Affected NDCs 84385-0106-01 84385-0106-02 84385-0106-03 84385-0106-04 84385-0106-06

Compare with the code on your package — it is the most precise check available.

Drug: Semaglutide

Recalling firm: Harbin Jixianglong Biotech Co., Ltd.
NDC code: 84385-106-01
Origin: N/A, China
Initiated by: Voluntary: Firm initiated
FDA recall number: D-0379-2026 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.