FDA Reports Recall of Apollo Care Semaglutide Vials Over Particulate Matter

On August 19, 2026, the FDA reported a recall of certain semaglutide vials distributed nationwide, citing the presence of particulate matter.

2 reports on this incident · first at Aug 25, 2026, 4:15 p.m. ET

By AI ReporterWritten Aug 25, 2026, 4:24 p.m. ET

The U.S. Food and Drug Administration reported on August 19, 2026, a recall of semaglutide vials manufactured by , of , Missouri, according to the agency's enforcement report (recall number ). The recall, initiated July 29, 2026, was classified as , meaning the product may cause temporary or medically reversible harm and the chance of serious harm is remote, per FDA definitions. The affected product is Semaglutide 2.5mg (1mg/mL), Glycine 12.5 mg (5mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, NDC 71170-711-02, lot AC-017271, exp. 12/12/2026. The recall was issued due to the presence of particulate matter identified as nylon/polyamide and silk/proteinaceous-type material. The FDA's database records no other enforcement action by this firm. The recall, which involved 250 vials distributed nationwide, is listed as "" in the enforcement report. Consumers who have the product with the specified lot and expiration date should check the FDA's recall notice for guidance.

Earlier reports

Aug 25, 2026, 4:15 p.m. ETFirst report
Apollo Care Recalls Semaglutide Vials Over Particulate Matter
Apollo Care, LLC of Columbia, Missouri, is recalling 250 vials of semaglutide injection, according to an FDA enforcement report dated August 19, 2026. The recall, initiated July 29, 2026, covers lot code AC-017271 with expiration date 12/12/2026. The product is a sterile multi-dose vial for subcutaneous injection, labeled as SEMAGLUTIDE 2.5mg (1mg/mL), Glycine 12.5 mg (5mg/mL), 2.5 mL, NDC 71170-711-02.
The FDA classified the recall as Class II, meaning the product may cause temporary or medically reversible harm and the chance of serious harm is remote. The reason for the recall is the presence of particulate matter identified as nylon/polyamide and silk/proteinaceous-type material. The recall is ongoing and distributed nationwide within the U.S.
The FDA enforcement report lists the recall number as D-0753-2026. The FDA database records no other enforcement action by this firm.

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Version 125 Aug 2026, 20:15current
First published.
Version 125 Aug 2026, 20:24current
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