Harbin Jixianglong Biotech Co. recalled Semaglutide for Rx compounding use nationwide in the United States. The recall cites CGMP deviations and failure to complete endotoxin validation before distribution. Healthcare providers and patients should stop using the product immediately and contact the company or a healthcare provider for guidance via email.
CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
Consumers and healthcare providers should stop using this product immediately. Contact Harbin Jixianglong Biotech Co., Ltd. or your healthcare provider for guidance. Notification method: E-Mail
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Semaglutide for Rx compounding is used to prepare customized pharmaceutical products for patients under medical supervision.
CGMP deviations and lack of validated endotoxin testing raise risk of contaminated injectable product and possible infection.
This recall is not described as part of a broader industry pattern.
Potential endotoxin exposure could lead to severe infection in patients requiring medical treatment.
FDA enforcement recall page for D-0380-2026; recall notice details.
Not specified by the recall notice; use FDA guidance and company contact for updates.
Save recall notice, batch numbers, manufacturer contact, and medical records if exposure occurs.
Product: Semaglutide for Rx compounding use only. Packaging sizes and NDCs: 1 g (84385-106-01); 5 g (84385-106-02); 10 g (84385-106-06); 25 g (84385-106-03); 50 g (84385-106-04); 100 g (84385-106-05). Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street, Limin Development Zone, Harbin, China. Distribution: Nationwide in the United States. Recall Date: 2026-02-13. Report Date: 2026-03-11. Classification: Class II. Quantity: N/A.
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