FDA Issues Class II Recall for Semaglutide 12.5MG/mL Due to Particulate Matter
Last updated 2026-08-31 · Source: FDA
Primary source: FDA: FDA Issues Class II Recall for Semaglutide 12.5MG/mL Due to Particulate Matter
The U.S. Food and Drug Administration (FDA) has announced a Class II recall for a specific lot of SEMAGLUTIDE 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial, manufactured by Apollo Care, LLC. The recall was initiated due to the presence of particulate matter, specifically identified as nylon/polyamide and silk/proteinaceous-type material, in the injectable product. This nationwide recall, initiated on July 29, 2026, is ongoing and affects products distributed across the United States.
What this means for your practice
This FDA Class II recall underscores the critical importance of supply chain vigilance and product quality assurance for all healthcare businesses, including telehealth brands, medspas, dental practices, and chiropractic offices, particularly those involved in prescribing or administering injectable medications like semaglutide. Practices utilizing or dispensing semaglutide products must immediately check their inventory against the recall notice to ensure no affected vials are in use or circulation. The presence of particulate matter in injectable drugs poses potential health risks to patients, ranging from localized reactions to serious systemic issues, depending on the nature and size of the particles. Providers are reminded of their responsibility to verify the integrity and origin of all pharmaceuticals used in their practice, maintaining thorough documentation and adherence to dispensing and administration protocols. Implementing robust internal checks and staying informed on FDA recalls are essential components of patient safety and regulatory compliance.
Washington D.C. — The U.S. Food and Drug Administration (FDA) has announced a Class II recall impacting a specific formulation of semaglutide, a medication widely used for diabetes management and weight loss. The recall, identified as D-0747-2026, concerns SEMAGLUTIDE 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial, intended for subcutaneous injection.
Product Details and Recall Reason
The affected product is SEMAGLUTIDE 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial, labeled as 'Rx Only' and 'For Subcutaneous Injection Only'. It is associated with the NDC 71170-495-05. The recalling firm is Apollo Care, LLC, located at 3801 Mojave Ct, Ste 102, Columbia, MO 65202.
The primary reason for this recall is the
Key Facts
| Detail | Value | |---|---| | Recall Number | D-0747-2026 | | Product | SEMAGLUTIDE 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only | | Recalling Firm | Apollo Care, LLC | | Reason for Recall | Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material | | Distribution | Nationwide within the U.S. | | Status | Ongoing; initiated 20260729; reported 20260819 |
Frequently Asked Questions
What specific product is subject to this FDA recall?
The recalled product is SEMAGLUTIDE 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial, designated 'Rx Only' and 'For Subcutaneous Injection Only'.
Who is the firm responsible for this recall?
The recalling firm is Apollo Care, LLC, located at 3801 Mojave Ct, Ste 102, Columbia, MO 65202.
Why was this particular semaglutide product recalled?
The recall was initiated due to the presence of particulate matter within the product, which was identified as a nylon/polyamide and silk/proteinaceous-type material.
What is the classification of this recall?
This is categorized as a Class II recall by the FDA.
How extensive is the distribution of the recalled product?
The product was distributed nationwide across the United States.
Source: FDA — FDA Recall D-0747-2026: SEMAGLUTIDE 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcut · 2026-08-19