# FDA recall D-0380-2026

> **Harbin Jixianglong Biotech Co., Ltd.** · Class II · drug recall initiated 2026-02-13.

## 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.

## Reason for recall

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

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0380-2026
- **Recalling firm:** Harbin Jixianglong Biotech Co., Ltd.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-02-13
- **Report date:** 2026-03-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Haerbin, N/A, China

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0380-2026

## Citation

> AI Analytics. FDA recall D-0380-2026. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/D-0380-2026. Source: US FDA. Licensed CC0.

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