Fibrous particulate in semaglutide injection prepared by a compounding facility — 9,762 vials covered
Semaglutide 4.5 mg (0.9 mg/mL) in 5 mL sterile multi-dose vials prepared by Apollo Care was recalled for the presence of particulate matter identified as nylon/polyamide and silk/proteinaceous-type material. 9,762 vials are covered, classification is Class II, and distribution was nationwide.
Recall overview (primary data)
- ClassificationClass II
- Product typeDrug
- Recalling firmApollo Care, LLC
- ReasonPresence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
- DistributionNationwide within the U.S
- Recall initiated2026-07-29
Key points
- 9,762 vials of semaglutide 4.5 mg (0.9 mg/mL) in 5 mL sterile multi-dose vials prepared by Apollo Care are covered by the recall.
- The reason is particulate matter identified as nylon/polyamide and silk/proteinaceous-type material.
- Classification is Class II. Recall initiation was 2026-07-29, the report date 2026-08-19, and distribution was nationwide.
- A separate strength from the same firm — semaglutide 5 mg with glycine 25 mg, 250 vials — carries a record for the same reason.
- Of the 1,408 records this site holds as of 2026-09-02, 49 mention particulate in the recall reason.
1Fibres in an injectable
Particulate in an injectable carries different weight from particulate in an oral product, because it enters tissue or the bloodstream without passing through the digestive tract. The material identified here is recorded as nylon/polyamide and silk/proteinaceous-type. That it could derive from both synthetic and natural fibre points toward materials used in manufacturing or filling.
2Where the particulate type sits
Particulate accounts for 49 of the 1,408 records this site holds as of 2026-09-02. Fewer than the 353 for sterility and microbial contamination, but the consequence is larger for products whose route of administration is direct. A separate strength from the same firm — semaglutide 5 mg with glycine, 250 vials — carries a record for the same reason, so the effect reached across products sharing a lot or a process.
3Compounding and outsourced preparation
Semaglutide is known as a GLP-1 receptor agonist, and rising demand has meant supply not only through large pharmaceutical manufacturers but through facilities preparing it against individual prescriptions. This case falls in that second category. Mass-manufactured medicines and prescription-compounded products sit under different quality frameworks at different scales.
When reading recall records, telling which framework produced a product helps in understanding the character of the case.
4What the classification indicates
The classification is Class II, which covers 1,089 of the 1,408 records this site holds as of 2026-09-02. Classification reflects an assessment of the likelihood and seriousness of harm from using the product. The recall was begun by the firm itself; among the same 1,408 records at that date, 1,392 were firm-initiated.
If you are using the product, do not stop on your own judgment; follow healthcare professionals and the official information from the FDA and the manufacturer.
Why it matters
A case where quality control on the compounding route surfaced as a recall record, at a time when a high-demand ingredient is supplied through that route as well. That the effect reached multiple strengths sharing a process also speaks to the relationship between preparation scale and control systems.
FAQ
Why does particulate matter more in an injectable?
Is this different from a large manufacturer product?
Sources (primary)
Source: openFDA (U.S. FDA, CC0 public domain). Data is provided as-is and must not be used for medical decisions. Verify the latest and exact details with the official FDA recall information. This site is not endorsed or certified by the U.S. FDA.
- FDA recall information (official)
- openFDA (data provider)
- Recall number: D-0750-2026