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

What this means for your practice

This recall of an injectable Semaglutide product due to particulate matter presents a significant compliance and patient safety concern for telehealth brands, medspas, and other healthcare practices that prescribe or administer this medication. Practices must immediately identify if they have any affected product lots, quarantine them, and follow the recalling firm's instructions for return or destruction. Beyond inventory management, it is critical to assess patient records for individuals who may have received the recalled product and implement a communication strategy in consultation with medical staff and legal counsel. Failure to act promptly and effectively can expose practices to regulatory penalties, patient harm, and reputational damage. Comprehensive internal audits of drug sourcing and handling protocols are also advisable.

WASHINGTON D.C. — The U.S. Food and Drug Administration (FDA) has issued a Class II drug enforcement recall, D-0754-2026, for specific lots of Semaglutide and Glycine sterile multi-dose vials manufactured by Apollo Care, LLC. This recall, initiated on July 29, 2026, and reported on August 19, 2026, is a nationwide action prompted by the discovery of particulate matter within the product.

Product Details and Reason for Recall

The recalled product is SEMAGLUTIDE 5mg (1mg/mL), Glycine 25 mg (5mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only. It is distributed under the APOLLO care label from their facility at 3801 Mojave Ct, Ste 102, Columbia, MO 65202. The affected product carries NDC 71170-712-03.

The primary reason for this recall is the "Presence of Particulate Matter." The FDA has identified this foreign material as a "nylon/polyamide and silk/proteinaceous-type material." The introduction of foreign particles into injectable medications can pose serious health risks to patients, depending on the nature and size of the particles, and the patient's underlying health status.

Understanding Class II Recalls

The FDA classifies recalls into three categories: Class I, Class II, and Class III, based on the degree of hazard involved. A Class II recall signifies a situation where 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. For an injectable product like Semaglutide, the presence of particulate matter necessitates careful evaluation of potential patient harm, which can range from localized irritation or inflammatory reactions at the injection site to more systemic issues if the particles enter the bloodstream.

Implications for Healthcare Practices

Healthcare providers, including telehealth platforms, medspas, dental practices, and chiropractic offices that prescribe, dispense, or administer Semaglutide, must treat this recall with immediate attention. The nationwide distribution means that a broad range of practices across the U.S. could be affected.

Key actions for healthcare businesses include:

• Immediate Inventory Review: All practices should conduct a thorough review of their current drug inventory to identify if any vials of Apollo Care's Semaglutide (NDC 71170-712-03) are present. This includes examining stock on shelves, in pharmacies, and any patient-supplied medications if applicable to your practice model.
• Quarantine Affected Product: Any identified recalled product must be immediately segregated from usable inventory and quarantined in a secure location to prevent inadvertent use. Clearly label the quarantined stock as "RECALLED - DO NOT USE."
• Follow Recalling Firm Instructions: Apollo Care, LLC, as the recalling firm, will provide specific instructions for the return or destruction of the affected product. Practices must adhere strictly to these instructions to ensure proper handling and documentation of the recall process. This typically involves contacting the manufacturer or distributor for a return goods authorization (RGA) or specific disposal guidelines.
• Patient Identification and Communication: A critical step is to identify all patients who may have been prescribed or administered the recalled product. Clinical judgment, guided by the potential risks associated with particulate matter, will dictate the necessity and urgency of patient outreach. This may involve notifying patients, advising them to inspect their medication, and discussing potential symptoms or concerns. Any patient communication should be done in consultation with medical and legal counsel to ensure compliance and minimize liability.
• Documentation: Maintain meticulous records of all actions taken in response to the recall. This includes inventory checks, quantities identified, communications with the recalling firm, patient outreach efforts, and any adverse events reported by patients. Proper documentation is crucial for demonstrating compliance with regulatory requirements and for potential liability defense.
• Adverse Event Reporting: Healthcare professionals are encouraged to report any adverse reactions or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program. This data helps the FDA monitor product safety and effectiveness.

Regulatory Landscape and Future Considerations

This recall underscores the continuous regulatory scrutiny on pharmaceutical compounding and manufacturing. The FDA vigorously monitors drug quality to protect public health, and recalls are a critical mechanism to remove potentially harmful products from the market. For practices engaging in telehealth prescribing, medspa services, or other forms of care that involve medication, vigilance regarding drug recalls is paramount. Robust internal procedures for managing drug inventory, verifying product authenticity, and staying abreast of FDA alerts are essential components of a strong compliance program.

Moving forward, practices should review their supplier vetting processes to ensure they are sourcing medications from reputable and compliant manufacturers and distributors. The incident also serves as a reminder for all healthcare providers to educate themselves and their staff on the nuances of drug recalls and the appropriate steps to take when such events occur, thereby safeguarding patient health and maintaining regulatory integrity.

Source

FDA Drug Enforcement/Recall D-0754-2026

Key Facts

| Detail | Value | |---|---| | Recall Number | D-0754-2026 | | Product | SEMAGLUTIDE 5mg (1mg/mL), Glycine 25 mg (5mg/mL), 5 mL Sterile Multi-Dose Vial | | Manufacturer | Apollo Care, LLC | | NDC | 71170-712-03 | | 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 product is being recalled?

The recalled product is SEMAGLUTIDE 5mg (1mg/mL), Glycine 25 mg (5mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, with NDC 71170-712-03.

Who is the manufacturer of the recalled product?

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

Why is this product being recalled?

The product is being recalled due to the presence of particulate matter, specifically identified as a nylon/polyamide and silk/proteinaceous-type material.

What is the classification of this recall?

This is a Class II recall, meaning use of or exposure to the product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the recalled product distributed?

The product was distributed nationwide within the U.S.

Source: FDA — FDA Recall D-0754-2026: SEMAGLUTIDE 5mg (1mg/mL), Glycine 25 mg (5mg/mL), 5 mL Sterile Multi-Dose Vial, · 2026-08-19