FDA Issues Class II Recall for Apollo Care's Semaglutide Due to Particulate Matter
Last updated 2026-09-03 · Source: FDA
Primary source: FDA: FDA Issues Class II Recall for Apollo Care's Semaglutide Due to Particulate Matter
The FDA has announced a Class II recall for Semaglutide 2.25MG (0.9 mg/mL), 2.5 mL Sterile Multi-Dose Vials, manufactured by Apollo Care, LLC. The recall was initiated due to the presence of particulate matter, identified as nylon/polyamide and silk/proteinaceous-type material, in the injectable product. This recall affects product distributed nationwide within the U.S.
What this means for your practice
This recall underscores the critical importance of robust supply chain management and vigilant product integrity checks for all healthcare practices, including telehealth brands, medspas, and general medical clinics. Providers administering or dispensing Semaglutide must immediately verify their inventory against the recalled NDC and firm to ensure patient safety. The presence of particulate matter in an injectable product carries inherent risks, and adherence to recall procedures is paramount for compliance and preventing adverse patient outcomes. Practices utilizing compounded or specialty pharmaceuticals must be especially diligent in confirming the quality and sourcing of all medications.
The U.S. Food and Drug Administration (FDA) has announced a Class II recall for a specific lot of Semaglutide manufactured by Apollo Care, LLC. This regulatory action, identified as FDA Recall D-0748-2026, involves Semaglutide 2.25MG (0.9 mg/mL), 2.5 mL Sterile Multi-Dose Vials, indicated for subcutaneous injection only and available by prescription.
The recall was initiated by Apollo Care, LLC on July 29, 2026, and officially reported by the FDA on August 19, 2026. The primary reason for this action is the discovery of particulate matter within the sterile multi-dose vials. The foreign material has been identified as a nylon/polyamide and silk/proteinaceous-type material.
Understanding the Recall
Product Identification
The recalled product is specifically: * Product Name: SEMAGLUTIDE 2.25MG (0.9 mg/mL) * Presentation: 2.5 mL Sterile Multi-Dose Vial * Usage: Rx Only, For Subcutaneous Injection Only * Manufacturer/Labeler: APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202 * National Drug Code (NDC): 71170-811-02
Recalling Firm
The recall was initiated by Apollo Care, LLC, the firm responsible for the product. This indicates their active role in identifying and addressing the quality concern.
Reason for Recall: Particulate Matter
The presence of particulate matter in injectable drugs is a serious quality defect that can pose significant health risks to patients. While the specific impact in this instance is not detailed beyond the classification, foreign particles, when injected, can potentially lead to a range of adverse health consequences. These may include localized reactions at the injection site, such as inflammation or granuloma formation. In more severe cases, particularly if the particles are introduced systemically, they could potentially contribute to vascular occlusion or immunological responses. The identification of the particulate matter as nylon/polyamide and silk/proteinaceous-type material provides specific insight into the nature of the contamination.
Recall Classification: Class II
The FDA designates recalls with a classification that reflects the degree of hazard associated with the product. A Class II recall signifies 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 classification indicates that while the risk of severe, permanent harm is considered low, there is still a potential for temporary or reversible adverse health effects, making corrective action necessary.
Distribution and Status
The affected product was distributed nationwide within the U.S. The recall status is currently
Key Facts
| Detail | Value | |---|---| | Recall Number | D-0748-2026 | | Product | SEMAGLUTIDE 2.25MG (0.9 mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only | | NDC | 71170-811-02 | | Reason for Recall | Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material | | Recalling Firm | Apollo Care, LLC | | Distribution | Nationwide within the U.S. | | Recall Status | Ongoing; initiated 20260729; reported 20260819 |
Frequently Asked Questions
What specific product is subject to this FDA recall?
The recalled product is SEMAGLUTIDE 2.25MG (0.9 mg/mL), 2.5 mL Sterile Multi-Dose Vial, which is Rx Only and intended For Subcutaneous Injection Only, with NDC 71170-811-02.
Who is the firm recalling this Semaglutide product?
The recalling firm is Apollo Care, LLC, located at 3801 Mojave Ct, Ste 102, Columbia, MO 65202.
What is the reason for the recall?
The recall is due to the presence of particulate matter in the product, specifically identified as a nylon/polyamide and silk/proteinaceous-type material.
What is the classification of this recall?
This is classified as an FDA Class II Drug Enforcement/Recall.
Where was the recalled Semaglutide distributed?
The product was distributed nationwide within the U.S.
Source: FDA — FDA Recall D-0748-2026: SEMAGLUTIDE 2.25MG (0.9 mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Sub · 2026-08-19