Recalls / Class II

Class IID-0380-2026

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, East of Changqing Street, Limin Development Zone, Harbin, China.

Affected lot / code info

Batch # CP-030-20250911, Mfg Date: Sep. 25th, 2025, Retest Date: Sep. 24th, 2027.

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

Recalling firm

Firm

Harbin Jixianglong Biotech Co., Ltd.

Notification channel

E-Mail

Type

Voluntary: Firm initiated

Address

North Of Baoan Road, East Of Changqing Street, Hulan District, Haerbin, N/A N/A, China

Distribution

Quantity

N/A

Distribution pattern

Nationwide within the United States

Timeline

Recall initiated

2026-02-13

FDA classified

2026-03-02

Posted by FDA

2026-03-11

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0380-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.