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High risk Drugs & MedicationsClass II

Harbin Jixianglong Semaglutide Recall

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, ND

Updated February 13, 2026

Harbin Jixianglong Biotech is recalling semaglutide powder used for pharmacy compounding due to incomplete process and bacterial endotoxin testing before shipment. Pharmacies may have received untested product.

Is the Harbin Jixianglong Biotech Co., Ltd. recalled? Yes. This product was recalled by FDA on February 13, 2026. Details below.

What is recalled

Semaglutide powder for Rx compounding use only, manufactured by Harbin Jixianglong Biotech Co., Ltd. Sizes and NDC numbers: 1g (NDC 84385-106-01), 5g (NDC 84385-106-02), 10g (NDC 84385-106-06), 25g (NDC 84385-106-03), 50g (NDC 84385-106-04), and 100g (NDC 84385-106-05).

Am I affected

You're affected if your pharmacy received semaglutide powder from Harbin Jixianglong Biotech with the NDC numbers listed above, or if you received a compounded semaglutide medication made from this recalled bulk powder after February 13, 2026.

What to do right now

If you are a pharmacy or healthcare provider, stop dispensing this product immediately and contact your supplier or the FDA. If you received a prescription for compounded semaglutide, contact your pharmacy to confirm whether your medication was made from this recalled powder and follow their guidance.

The hazard

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

Brands affected

Harbin Jixianglong Biotech Co., Ltd.
Source
FDA
Category
Drugs & Medications
Recall ID
fda-D-0380-2026
Classification
Class II
Recalled
February 13, 2026
Read the official notice

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