Semaglutide compounding ingredient recalled over incomplete process and endotoxin validation
Harbin Jixianglong Biotech is recalling Semaglutide for prescription compounding use because process validation and bacterial endotoxin method validation were not completed before distribution.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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), 50 g (84385-106-04) and 100 g (84385-106-05) 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 batch CP-030-20250911, manufactured 25 September 2025, with a retest date of 24 September 2027.
Compounding pharmacies can identify affected product by the NDC and batch 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; e) 100g, NDC 84385-106-05Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan…
- Manufacturer
- Harbin Jixianglong Biotech Co., Ltd.
- Category
- Drug — Compounding ingredient
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 (5)
- Batch # CP-030-20250911
- Mfg Date: Sep. 25th
- 2025
- Retest Date: Sep. 24th
- 2027.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Harbin Jixianglong Biotech Co., Ltd. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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