FDA Issues Class II Recall for Apollo Care's Semaglutide Due to Particulate Matter

What this means for your practice

This Class II recall of a widely used medication like Semaglutide highlights the critical importance of robust supply chain management, stringent product inspection, and adherence to patient safety protocols for all healthcare practices. Practices, especially medspas and telehealth providers that manage or administer injectable medications, must meticulously vet their pharmaceutical suppliers and ensure all products undergo visual inspection upon receipt. Any compromised product can pose significant patient safety risks, including infection, immune reactions, or embolic events. This incident underscores the ongoing regulatory scrutiny on product quality for compounded or specialty pharmaceuticals and necessitates an immediate review of inventory for affected lots and appropriate patient notification procedures.

Washington, D.C. – The U.S. Food and Drug Administration (FDA) has announced a Class II drug recall for specific lots of Semaglutide 4.5mg (0.9 mg/mL), 5 mL Sterile Multi-Dose Vials manufactured and distributed by Apollo Care, LLC. The recall was initiated due to the confirmed presence of particulate matter within the vials, identified as nylon/polyamide and silk/proteinaceous-type material. This regulatory action underscores the FDA's commitment to ensuring the safety and quality of pharmaceutical products available to the public.

Details of the Recall

The recalled product is SEMAGLUTIDE 4.5mg (0.9 mg/mL), 5 mL Sterile Multi-Dose Vial, designated as Rx Only and intended for subcutaneous injection. The product carries the NDC 71170-812-03 and is associated with Apollo Care, LLC, located at 3801 Mojave Ct, Ste 102, Columbia, MO 65202. The recall number assigned by the FDA is D-0750-2026.

According to the FDA enforcement report, the recall was initiated on July 29, 2026, and publicly reported on August 19, 2026. The distribution of the affected product was nationwide within the United States. The status of the recall is currently ongoing, indicating that efforts to remove the product from the market are still in progress.

Understanding Class II Recalls

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. In the context of injectable medications, the presence of particulate matter can pose various health risks to patients. These risks can include localized irritation at the injection site, systemic inflammatory responses, allergic reactions, or, in more severe cases, embolic events if the particles obstruct blood vessels. The specific nature of the particulate matter – nylon/polyamide and silk/proteinaceous-type material – indicates a potential manufacturing or packaging defect.

Risks Associated with Particulate Matter in Injectables

Particulate matter in injectable drugs is a significant concern for patient safety. Such foreign substances, when introduced into the body, can lead to adverse events including:

• Vascular Occlusion: Particles can block small blood vessels, leading to tissue damage or infarction, particularly concerning if injected intravenously or if they migrate to critical organs.
• Inflammation and Granuloma Formation: The body's immune system may react to foreign particles, causing local inflammation, pain, or the formation of granulomas (small areas of inflammation).
• Infection: Non-sterile particulate matter can introduce bacteria or other microorganisms, leading to serious infections.
• Allergic Reactions: Certain materials, including proteins (silk/proteinaceous-type material), can trigger allergic or hypersensitivity reactions in susceptible individuals.

These risks highlight why pharmaceutical manufacturers must maintain stringent quality control measures to prevent the introduction of foreign substances during the production and packaging processes of sterile injectable products.

Manufacturer Responsibilities and Regulatory Oversight

Pharmaceutical manufacturers are held to strict Good Manufacturing Practice (GMP) standards enforced by the FDA. These standards are designed to ensure the quality, purity, and safety of drug products. Deviations from GMP, such as the presence of particulate matter, can lead to significant regulatory actions, including product recalls, warning letters, and even facility closure if systemic issues are identified.

Apollo Care, LLC, as the recalling firm, is responsible for notifying its customers and ensuring the efficient retrieval and disposition of the recalled product. This involves identifying all affected lots, communicating recall instructions to distributors and healthcare providers, and providing regular updates to the FDA on the recall's progress.

What This Means for Healthcare Providers

Healthcare providers, including telehealth brands, medspas, dental practices, and chiropractic offices that prescribe, dispense, or administer Semaglutide or similar injectable medications, must be acutely aware of this recall. The nationwide distribution indicates that a broad range of practices may have received or currently possess the affected product.

Providers should immediately:

• Identify Affected Inventory: Check all existing stock of Semaglutide vials against the NDC and product description provided in the recall notice.
• Quarantine and Return: Segregate and cease the use of any identified affected product. Follow Apollo Care, LLC's specific instructions for returning the product.
• Patient Notification: Assess whether any patients have received the recalled product and determine if patient notification or follow-up is necessary based on clinical judgment and potential risk.
• Review Sourcing Practices: Re-evaluate procurement processes to ensure that all pharmaceutical products, especially compounded or specialty injectables, are sourced from reputable and FDA-compliant manufacturers or compounding pharmacies. Diligence in supplier qualification is paramount.
• Training and Vigilance: Reinforce training for staff involved in handling and administering medications on the importance of visual inspection of injectable products for any signs of contamination or particulate matter prior to administration.

This recall serves as a critical reminder of the continuous need for vigilance in pharmaceutical supply chain management and patient safety protocols. The FDA remains committed to monitoring drug quality and taking necessary actions to protect public health.

Key Facts

| Detail | Value | |---|---| | Recall Number | D-0750-2026 | | Product | SEMAGLUTIDE 4.5mg (0.9 mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only | | 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. | | Status | Ongoing; initiated 2026-07-29; reported 2026-08-19 |

Frequently Asked Questions

Which specific product is being recalled?

The recalled product is SEMAGLUTIDE 4.5mg (0.9 mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, with NDC 71170-812-03.

Why was this product recalled?

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

Who is the recalling firm?

The recalling firm is Apollo Care, LLC, located at 3801 Mojave Ct, Ste 102, Columbia, MO 65202.

Where was this product distributed?

The product was distributed nationwide within the U.S.

What is the status of the recall?

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

Source: FDA — FDA Recall D-0750-2026: SEMAGLUTIDE 4.5mg (0.9 mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcut · 2026-08-19