FDA Closes Recall of Apollo Care Semaglutide Vials
The agency has closed the recall of certain semaglutide vials due to particulate matter, considering the action carried out.
2 reports on this incident · first at Aug 25, 2026, 5:21 p.m. ET
Earlier reports
Aug 25, 2026, 5:21 p.m. ETFirst report
FDA Class II Recall Issued for Apollo Care Semaglutide Vials Due to Particulate Matter
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for a compounded semaglutide product manufactured by Apollo Care, LLC of Columbia, Missouri. The recall, identified as D-0756-2026, was initiated on July 29, 2026, and reported on August 19, 2026. The product is Semaglutide 10mg (5mg/mL), Glycine 10 mg (5mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, with NDC 71170-722-02. The affected lot is AC-017274, with an expiration date of 12/12/2026. The recall covers 500 vials distributed nationwide within the U.S.
The reason for the recall is the presence of particulate matter, identified as a nylon/polyamide and silk/proteinaceous-type material. According to the FDA, a Class II recall is used when a product may cause temporary or medically reversible harm, and where the chance of serious harm is remote. The recall is ongoing.
The FDA enforcement report lists Apollo Care, LLC as the recalling firm. The FDA database records no other enforcement action by this firm. Consumers who have this product should check the lot number and expiration date. The FDA advises that consumers should not use the recalled product and should contact their healthcare provider or the pharmacy for guidance.
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Revision history
- Version 125 Aug 2026, 21:21current
First published.
- Version 125 Aug 2026, 21:24current
First published.
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