FDA Issues Nationwide Class II Recall for Semaglutide/Glycine Sterile Multi-Dose Vials Due to Particulate Matter

What this means for your practice

This nationwide recall highlights the persistent regulatory scrutiny on the quality and safety of injectable medications, particularly those compounded or distributed by smaller firms. For telehealth platforms, medspas, dental practices, chiropractic offices, and other healthcare businesses that prescribe or administer medications like semaglutide, this event serves as a critical reminder of the need for robust vendor qualification and ongoing monitoring processes. Practices must immediately verify if they have received any affected lots of this specific product from Apollo Care, LLC, or any distributor supplied by them. Adherence to recall procedures, including quarantine of affected product and patient notification where appropriate, is paramount to ensure patient safety and maintain compliance with federal regulations. Providers should maintain meticulous records of all medications purchased, prescribed, and administered, enabling swift action in the event of a recall. The FDA's Class II designation indicates that use of or exposure to the recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

WASHINGTON D.C. — The U.S. Food and Drug Administration (FDA) has initiated a nationwide Class II recall for specific lots of a Semaglutide and Glycine combination product, citing the presence of particulate matter. The recalled product is identified as SEMAGLUTIDE 2.5mg (1mg/mL), Glycine 12.5 mg (5mg/mL), 2.5 mL Sterile Multi-Dose Vial, labeled 'Rx Only, For Subcutaneous Injection Only,' and distributed under the 'APOLLO care' brand.

Details of the Recall

The recalling firm is Apollo Care, LLC, located at 3801 Mojave Ct, Ste 102, Columbia, MO 65202. The affected product bears NDC 71170-711-02. The recall was formally initiated on July 29, 2026, and was reported to the FDA on August 19, 2026, with an 'Ongoing' status.

Reason for Recall

The primary reason for this recall is the confirmed presence of particulate matter within the sterile multi-dose vials. The FDA's report specifies that the particulates were identified as a nylon/polyamide and silk/proteinaceous-type material. Such foreign matter in injectable products poses a significant risk to patient safety, including the potential for local irritation, immune reactions, or, in severe cases, vascular occlusion if injected intravenously.

Recall Classification

This recall has been designated as a Class II recall. An FDA 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. Despite the 'remote' probability of serious harm, the presence of foreign particles in sterile injectables is a serious quality defect that necessitates immediate action to protect public health.

Distribution Scope

The affected product was distributed nationwide within the United States. This wide distribution underscores the potential breadth of impact on healthcare providers and patients across various states.

Implications for Healthcare Businesses

For telehealth providers, medspas, dental practices, chiropractic offices, and other healthcare businesses that utilize injectable medications, particularly compounded or specialty pharmaceuticals, this recall serves as a critical reminder of several key compliance and operational imperatives:

• Supply Chain Vigilance: Healthcare practices must maintain rigorous due diligence processes for vetting and monitoring their pharmaceutical suppliers. This includes verifying manufacturer and distributor credentials, assessing quality control measures, and staying abreast of any regulatory actions or recalls affecting their supply chain.
• Inventory Management: Robust inventory management systems are essential to quickly identify and quarantine any recalled products. Practices should have clear protocols for reviewing recall notifications and taking immediate action.
• Patient Safety and Communication: Providers who may have administered this recalled product should assess the need for patient notification and follow-up, especially if patients report any unusual symptoms post-injection. Maintaining comprehensive patient records, including specific lot numbers of administered medications, is crucial for such situations.
• Compliance with Good Dispensing Practices: Even if a practice does not directly compound medications, the responsibility to ensure the safety and quality of products dispensed or administered rests with the provider. This includes verifying product integrity upon receipt and before administration.
• Reporting Adverse Events: Healthcare professionals are encouraged to report any adverse events or product quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program.

Conclusion

The nationwide Class II recall of Semaglutide/Glycine sterile multi-dose vials by Apollo Care, LLC, due to particulate matter, reinforces the ongoing regulatory focus on pharmaceutical quality and patient safety. Healthcare businesses must proactively manage their pharmaceutical supply chains, adhere to recall procedures, and prioritize patient safety to mitigate risks and maintain regulatory compliance.

Key Facts

| Detail | Value | |---|---| | Recall Number | D-0753-2026 | | Product | SEMAGLUTIDE 2.5mg (1mg/mL), Glycine 12.5 mg (5mg/mL), 2.5 mL Sterile Multi-Dose Vial | | Recalling Firm | Apollo Care, LLC | | Reason for Recall | Presence of Particulate Matter (nylon/polyamide and silk/proteinaceous-type material) | | Recall Class | Class II | | Distribution | Nationwide within the U.S. | | Status | Ongoing; initiated 20260729; reported 20260819 |

Frequently Asked Questions

What product is being recalled?

The recalled product is SEMAGLUTIDE 2.5mg (1mg/mL), Glycine 12.5 mg (5mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, under the 'APOLLO care' brand (NDC 71170-711-02).

Who is the recalling firm?

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

Why was this product recalled?

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

What is the scope of this recall?

This recall has a nationwide distribution within the U.S.

What does a 'Class II' recall mean?

A Class II recall means that use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote.

Source: FDA — FDA Recall D-0753-2026: SEMAGLUTIDE 2.5mg (1mg/mL), Glycine 12.5 mg (5mg/mL), 2.5 mL Sterile Multi-Dose · 2026-08-19