FDA Issues Class II Recall for Compounded Semaglutide Due to Particulate Matter

What this means for your practice

For telehealth brands, medspas, dental practices, chiropractic offices, and other healthcare businesses prescribing or administering compounded medications, particularly sterile injectables, this recall serves as a critical reminder of the importance of robust supply chain diligence and patient safety protocols. The presence of particulate matter in an injectable product poses a direct risk of adverse events, including local irritation, inflammatory reactions, and potentially more serious complications if the particles reach the circulatory system. Providers must ensure that any compounded medications they source come from reputable facilities with stringent quality control measures. Regular auditing of medication suppliers and verification of their compliance records, including any past recall history, is paramount. Furthermore, practices should establish clear procedures for identifying, segregating, and returning recalled products, as well as for notifying affected patients. The 'Rx Only' and 'For Subcutaneous Injection Only' labels on the recalled product highlight the need for careful prescribing and administration oversight by licensed professionals, ensuring patients receive appropriate counseling on medication use and potential risks.

Washington D.C. — The U.S. Food and Drug Administration (FDA) has announced a Class II recall for a compounded Semaglutide product, underscoring the ongoing vigilance required in the pharmaceutical supply chain. This recall highlights critical issues surrounding the quality control of compounded sterile preparations and their distribution across the United States.

Product Identification and Recall Details

The recalled product is SEMAGLUTIDE 10mg (5mg/mL), Glycine 10 mg (5mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, manufactured by Apollo Care, LLC, located at 3801 Mojave Ct, Ste 102, Columbia, MO 65202. The product bears NDC 71170-722-02. The recall number assigned by the FDA is D-0756-2026.

The recall was initiated by Apollo Care, LLC, on July 29, 2026, and was subsequently reported by the FDA on August 19, 2026. The recall is currently ongoing.

Reason for Recall: Particulate Matter

The primary reason for this recall is the presence of particulate matter within the sterile multi-dose vials. The FDA has identified these foreign materials as a nylon/polyamide and silk/proteinaceous-type material. The presence of such particulates in an injectable product raises significant safety concerns.

Risks Associated with Particulate Matter

Injecting solutions containing particulate matter can pose various health risks to patients. Depending on the size, quantity, and nature of the particles, as well as the patient's individual health status, potential adverse effects can range from localized irritation and inflammatory reactions at the injection site to more severe systemic complications. These may include granuloma formation, immunological reactions, blockage of blood vessels (embolism), and potentially even organ damage, especially if the particles are introduced into the circulatory system.

Class II Recall Classification

This action is classified as a Class II recall by the FDA. A Class II recall is issued when the 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. While not as severe as a Class I recall, which involves a reasonable probability of serious adverse health consequences or death, a Class II recall still indicates a significant health risk that warrants immediate attention from healthcare providers and patients.

Nationwide Distribution

The recalled product was distributed nationwide within the U.S. This broad distribution footprint necessitates that healthcare providers across all states and territories review their inventory and patient records for potential exposure.

Regulatory Implications for Compounded Medications

Compounded medications play a vital role in patient care, offering customized solutions when FDA-approved drugs are not suitable or available. However, they are not subject to the same rigorous pre-market approval process as commercially manufactured drugs. Compounding pharmacies and outsourcing facilities are instead regulated by state boards of pharmacy and, in certain circumstances, by the FDA under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act. This recall reinforces the FDA's commitment to monitoring the quality and safety of compounded drugs to ensure patient protection.

Action Required for Healthcare Practices

Healthcare businesses, including telehealth providers, medspas, dental practices, and chiropractic offices, that may have purchased or prescribed this specific compounded Semaglutide product should take immediate action:

• Identify Affected Inventory: Promptly check all medication inventory for the specific product details, including the NDC and lot numbers if available, to identify any units of SEMAGLUTIDE 10mg (5mg/mL), Glycine 10 mg (5mg/mL), 2 mL Sterile Multi-Dose Vial from Apollo Care, LLC.
• Quarantine and Return: Segregate and quarantine any identified affected product. Follow Apollo Care, LLC's instructions for returning the recalled medication.
• Patient Notification: Identify any patients who may have received the recalled product and initiate appropriate notification procedures. Provide clear guidance on potential risks and what steps, if any, they should take.
• Review Sourcing Practices: Evaluate current sourcing practices for compounded medications to ensure that all suppliers adhere to high-quality manufacturing and sterile compounding standards. Prioritize facilities with strong compliance records and robust quality management systems.
• Documentation: Maintain thorough documentation of all actions taken in response to this recall, including inventory checks, patient notifications, and product returns. This is crucial for regulatory compliance and patient safety records.

This recall serves as a crucial reminder that continuous vigilance over the quality and safety of all medications, especially those not subject to full FDA pre-market approval, is a non-negotiable aspect of healthcare delivery.

Key Facts

| Detail | Value | |---|---| | Recall Number | D-0756-2026 | | Product Recalled | SEMAGLUTIDE 10mg (5mg/mL), Glycine 10 mg (5mg/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; identified as a nylon/polyamide and silk/proteinaceous-type material | | Recall Classification | Class II | | 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 10mg (5mg/mL), Glycine 10 mg (5mg/mL), 2 mL Sterile Multi-Dose Vial, labeled 'Rx Only, For Subcutaneous Injection Only,' with NDC 71170-722-02.

Who is the recalling firm for this Semaglutide product?

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

Why was this specific Semaglutide product recalled?

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

What is the scope of distribution for the recalled product?

The product was distributed nationwide within the U.S.

What is the FDA's classification for this recall?

This recall is classified as a Class II recall.

Source: FDA — FDA Recall D-0756-2026: SEMAGLUTIDE 10mg (5mg/mL), Glycine 10 mg (5mg/mL), 2 mL Sterile Multi-Dose Vial, · 2026-08-19