FirstAlerts

FDA Closes Recall of Apollo Care Semaglutide Vials Over Particulate Matter

The FDA has closed the recall of certain semaglutide vials distributed nationwide, citing the presence of particulate matter.

2 reports on this incident · first at Aug 25, 2026, 4:22 p.m. ET

By AI ReporterWritten Aug 25, 2026, 4:23 p.m. ET
The U.S. Food and Drug Administration has closed the recall of certain semaglutide vials distributed by , of , Missouri, according to an FDA enforcement report dated August 19, 2026. The agency considers the recall carried out. The recall, initiated July 29, 2026, covers 4,250 vials of semaglutide 20 mg (5 mg/mL) and glycine 20 mg (5 mg/mL) in 4 mL sterile multi-dose vials, NDC 71170-724-04. The affected lots are AC-017275 (exp. 12/13/2026) and AC-017282, AC-017285 (exp. 12/27/2026). The reason given was the presence of particulate matter identified as nylon/polyamide and silk/proteinaceous-type material. The FDA classified this as a recall, meaning the product may cause temporary or medically reversible harm, with the chance of serious harm remote. The recall was distributed . The FDA's database records no other enforcement action by this firm.

Earlier reports

  1. Aug 25, 2026, 4:22 p.m. ETFirst report

    Apollo Care Recalls Semaglutide Vials Over Particulate Matter

    On August 19, 2026, the FDA posted an enforcement report for a recall initiated by Apollo Care, LLC of Columbia, Missouri, involving 4,250 vials of semaglutide injection. The recall, numbered D-0757-2026, was initiated on July 29, 2026, and is ongoing. The product is described as SEMAGLUTIDE 20mg (5mg/mL), Glycine 20 mg (5mg/mL), 4 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, with NDC 71170-724-04. The affected lots are AC-017275 (exp. 12/13/2026) and AC-017282, AC-017285 (exp. 12/27/2026).

    The reason for the recall is the presence of particulate matter, identified as a nylon/polyamide and silk/proteinaceous-type material. The FDA has classified this as a Class II recall, which the agency defines as a situation where the product may cause temporary or medically reversible harm, and where the chance of serious harm is remote. The recall is distributed nationwide within the U.S.

    The FDA enforcement report lists no other enforcement actions by Apollo Care, LLC. The recall status is ongoing.

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Revision history

  1. Version 125 Aug 2026, 20:22current

    First published.

  2. Version 125 Aug 2026, 20:23current

    First published.

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