Semaglutide compounding ingredient lot recalled over incomplete validation before distribution
Harbin Jixianglong Biotech is recalling a further lot of Semaglutide for prescription compounding because process validation and bacterial endotoxin method validation were not completed before distribution.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Rubric level 2 covers voluntary precautionary recalls: the source describes validation steps that were not completed rather than any contamination, hazard, illness or injury actually found.
Plain-English summary
Harbin Jixianglong Biotech Co., Ltd. is recalling Semaglutide, for prescription compounding use only, packaged in 1 g (NDC 84385-106-01), 5 g (84385-106-02), 10 g (84385-106-06), 25 g (84385-106-03) and 50 g (84385-106-04) sizes, manufactured in Harbin, China. The product was distributed nationwide within the United States. The FDA has classified this recall as Class II.
The recall was initiated for CGMP deviations, specifically failing to complete process validation and bacterial endotoxin method validation before distribution. The source record does not describe a specific hazard, illness or injury.
Affected product is lot CP-030-20250711, with an expiry date of 24 July 2027.
Compounding pharmacies can identify affected product by the NDC and lot number above, and may contact Harbin Jixianglong Biotech Co., Ltd. for further information.
The recalled product
- 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 Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street,
- Manufacturer
- Harbin Jixianglong Biotech Co., Ltd.
- Category
- Drug — Compounding ingredient
- Hazard
- gmp-deviation
- incomplete-validation
- precautionary-recall
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #: CP-030-20250711
- Exp. Date Jul. 24th
- 2027
Distribution
Distributed nationwide across the United States.
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