FDA Announces Class II Recall for Apollo Care Semaglutide Vials Due to Particulate Matter

What this means for your practice

This FDA Class II recall for an injectable Semaglutide product carries significant implications for telehealth brands, medspas, and other healthcare practices that prescribe or administer such medications. For providers utilizing Semaglutide for weight management, diabetes care, or other indications, immediate action is required to verify if their current inventory includes product from Apollo Care, LLC. The presence of particulate matter in an injectable medication poses a direct patient safety risk, potentially leading to adverse reactions at the injection site or more systemic issues if administered. Practices must promptly quarantine any affected product, cease dispensing or administering it, and follow the recalling firm's instructions for return or disposal. Furthermore, this incident underscores the critical importance of robust supply chain management and due diligence when sourcing pharmaceutical products. Relying on reputable manufacturers and distributors is paramount to ensuring patient safety and maintaining regulatory compliance. Telehealth providers, in particular, must ensure their prescribing and fulfillment partners adhere to stringent quality control measures to prevent similar issues from impacting patient care and practice integrity. While this specific recall targets an injectable product, the principles of vigilance apply broadly across all specialties and modalities.

Washington D.C. — The U.S. Food and Drug Administration (FDA) has announced a Class II recall for certain lots of Semaglutide 9mg (4.5 mg/mL), 2 mL Sterile Multi-Dose Vials, manufactured by Apollo Care, LLC. This significant action was initiated due to the confirmed presence of particulate matter within the injectable product, distributed nationwide within the United States.

Product Identification and Recall Details

The recalled product is specifically identified as: * Product Name: SEMAGLUTIDE 9mg (4.5 mg/mL), 2 mL Sterile Multi-Dose Vial * Dosage Form: Rx Only, For Subcutaneous Injection Only * Manufacturer: APOLLO Care, LLC, located at 3801 Mojave Ct, Ste 102, Columbia, MO 65202 * NDC: 71170-822-02

The recall, designated by the FDA as D-0751-2026, was officially initiated by Apollo Care, LLC, on July 29, 2026, and publicly reported by the FDA on August 19, 2026. The recall is currently ongoing.

Reason for the Recall: Particulate Matter Contamination

The primary reason for this recall is the detection of foreign particulate matter within the sterile multi-dose vials. Investigations have identified this material as a nylon/polyamide and silk/proteinaceous-type substance. The presence of such foreign particles in an injectable medication poses a potential risk to patient safety, which can range from localized irritation or infection at the injection site to more serious adverse events if the particles are introduced into the bloodstream.

Understanding a Class II Recall

A Class II recall is issued when a 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 is not immediately life-threatening, it warrants prompt action from healthcare providers and consumers to prevent potential harm.

Nationwide Distribution

The affected Semaglutide vials were distributed nationwide across the U.S. This broad distribution means that healthcare practices in any state could potentially possess or have dispensed the recalled product. Providers are urged to meticulously check their inventory regardless of their geographic location.

Implications for Healthcare Practices

For telehealth providers, medspas, and other healthcare entities that utilize or prescribe injectable Semaglutide, this recall necessitates immediate attention:

• Inventory Review: Practices must promptly identify if they have any affected lots of Semaglutide 9mg (4.5 mg/mL) 2 mL Sterile Multi-Dose Vials from Apollo Care, LLC, in their possession.
• Cessation of Use: Any identified recalled product must be immediately quarantined and removed from circulation. It should not be dispensed, administered, or distributed further.
• Patient Safety: While the recall is Class II, the potential for adverse reactions from particulate matter is real. Practices should assess if any patients have recently received the affected product and determine if follow-up communication or monitoring is necessary based on their clinical judgment.
• Compliance and Sourcing: This incident highlights the critical importance of rigorous vetting of pharmaceutical suppliers and maintaining meticulous records of drug provenance. Ensuring that all medications, especially injectables, are sourced from reputable and FDA-compliant manufacturers is a fundamental aspect of patient safety and regulatory adherence.
• Return/Disposal Procedures: Practices should await and follow specific instructions from Apollo Care, LLC, or their distributor regarding the proper return or disposal of the recalled product.

Maintaining patient trust and safety is paramount. Proactive management of this recall is essential for all healthcare providers, ensuring compliance with FDA regulations and upholding standards of care.

Source: FDA Drug Enforcement / Recall D-0751-2026

Key Facts

| Detail | Value | |---|---| | Product Recalled | SEMAGLUTIDE 9mg (4.5 mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only | | Recalling Firm | Apollo Care, LLC | | Reason for Recall | Presence of Particulate Matter (nylon/polyamide and silk/proteinaceous-type material) | | Recall Class | Class II | | Status | Ongoing; initiated 20260729; reported 20260819 | | Distribution | Nationwide within the U.S. |

Frequently Asked Questions

What specific product is subject to this FDA recall?

The recalled product is SEMAGLUTIDE 9mg (4.5 mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, with NDC 71170-822-02.

What is the reason for the recall of this Semaglutide product?

The recall is due to the presence of particulate matter, which has been identified as a nylon/polyamide and silk/proteinaceous-type material, found within the vials.

Which firm is responsible for this product and initiating the recall?

The recalling firm is Apollo Care, LLC, located in Columbia, MO.

What is the geographic scope of this recall?

The recalled product was distributed nationwide within the U.S.

What is the current status of this recall?

The recall is ongoing, having been initiated on July 29, 2026, and reported by the FDA on August 19, 2026.

Source: FDA — FDA Recall D-0751-2026: SEMAGLUTIDE 9mg (4.5 mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutan · 2026-08-19