FDA Recall: Semaglutide 0.9mg (0.9 mg/mL) Vials Recalled Due to Particulate Matter

What this means for your practice

This recall underscores the critical importance of supply chain vigilance and adherence to sterile compounding standards for all healthcare practices, including telehealth, medspas, and general medical clinics. Providers who have purchased or administered Semaglutide should immediately check their inventory against the specified product details, including the NDC 71170-810-01. Given the 'nationwide' distribution, all practitioners using Semaglutide injectables should consider reviewing their current stock. The presence of particulate matter in an injectable drug poses significant patient safety risks, including potential vascular occlusion, emboli, and foreign body reactions. Practitioners must isolate any affected products and follow the recalling firm's instructions for return or disposal. For telehealth providers or practices utilizing compounding pharmacies for Semaglutide, this event highlights the necessity of robust vendor qualification and ongoing quality assurance processes for all medications, particularly sterile injectables. Proactive communication with dispensing pharmacies and direct suppliers is paramount to ensure patient safety and maintain compliance.

Washington D.C. – The U.S. Food and Drug Administration (FDA) has announced a Class II recall for specific lots of SEMAGLUTIDE 0.9mg (0.9 mg/mL), 1 mL Sterile Multi-Dose Vials. The recall, identified as D-0752-2026, was initiated by Apollo Care, LLC due to the confirmed presence of particulate matter within the product. This regulatory action emphasizes the ongoing commitment to ensuring the safety and quality of pharmaceutical products available to the public.

Product Identification and Recall Details

The recalled product is SEMAGLUTIDE 0.9mg (0.9 mg/mL), 1 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, manufactured by APOLLO care, located at 3801 Mojave Ct, Ste 102, Columbia, MO 65202. The affected product bears the National Drug Code (NDC) 71170-810-01. This prescription-only medication is intended for subcutaneous injection, highlighting the critical nature of its sterility and purity.

Reason for Recall: Presence of Particulate Matter

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

Particulate matter in injectable drugs, even if microscopic, can pose various health risks. These risks include, but are not limited to:

• Vascular Occlusion: Particles can block blood vessels, leading to serious complications such as pulmonary emboli, stroke, or tissue ischemia.
• Phlebitis and Inflammatory Reactions: The foreign material can irritate blood vessel linings, causing inflammation at the injection site or along the vein.
• Granuloma Formation: The body's immune system may attempt to wall off foreign particles, leading to the formation of granulomas.
• Allergic Reactions: Proteinaceous materials, such as silk, could potentially trigger allergic or hypersensitivity reactions in susceptible individuals.
• Infection Risk: While not explicitly stated as contaminated, the presence of foreign material compromises the intended sterile environment of the drug.

Recall Classification: Class II

The FDA has designated this as a Class II recall. A Class II recall is initiated when the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or when the probability of serious adverse health consequences is remote. This classification indicates that while the risk of serious health consequences is not immediate or life-threatening for every exposure, it is a significant concern that warrants prompt action from the recalling firm and healthcare providers.

Recalling Firm and Distribution

The recall was initiated by Apollo Care, LLC, the manufacturer of the Semaglutide vials. The recall process began on July 29, 2026, and was reported to the FDA on August 19, 2026. The current status of the recall is ongoing, indicating that the firm is actively working to remove the affected product from the market and ensure all necessary actions are taken.

The distribution of the recalled product was nationwide within the U.S. This broad distribution footprint necessitates a comprehensive alert to healthcare providers and facilities across all states, including those serving telehealth patients or operating specialized clinics such as medspas and weight management centers that may utilize Semaglutide.

Implications for Healthcare Practices

Healthcare providers, including those in telehealth, medspas, dental practices, and chiropractic offices, who prescribe, dispense, or administer Semaglutide injectables, must take immediate action to review their inventory. It is imperative to:

1. Identify Affected Product: Carefully check all stock of Semaglutide vials against the specific product description, manufacturer (Apollo Care, LLC), and NDC (71170-810-01). 2. Quarantine and Discontinue Use: Immediately segregate and discontinue the use of any identified affected product. 3. Follow Recalling Firm's Instructions: Adhere to instructions provided by Apollo Care, LLC regarding the return, replacement, or disposal of the recalled product. This typically involves contacting the firm directly. 4. Patient Assessment: Evaluate any patients who may have received the affected product for potential adverse events. While the recall is Class II, vigilance for signs or symptoms related to particulate matter injection is prudent. 5. Supply Chain Integrity: Reinforce due diligence processes for sourcing and procuring all medications, especially sterile injectables. Ensure that all suppliers are reputable and that products are received and stored under appropriate conditions. 6. Documentation: Maintain meticulous records of inventory checks, quarantined products, and any communications with the recalling firm or regulatory bodies.

This recall serves as a critical reminder for all healthcare entities to maintain robust quality control processes and remain vigilant regarding drug product safety and supply chain integrity. Patient safety must always be the highest priority, and prompt action in response to drug recalls is a fundamental aspect of responsible practice.

Key Facts

| Detail | Value | |---|---| | Recall Number | D-0752-2026 | | Product | SEMAGLUTIDE 0.9mg (0.9 mg/mL), 1 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only | | NDC | 71170-810-01 | | Recalling Firm | Apollo Care, LLC | | Reason for Recall | Presence of Particulate Matter; identified as a 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 specifically being recalled?

The recalled product is SEMAGLUTIDE 0.9mg (0.9 mg/mL), 1 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, with NDC 71170-810-01.

Who is the recalling firm?

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

Why is this Semaglutide product being recalled?

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

What is the scope of the recall's distribution?

The product was distributed nationwide within the U.S.

What is the current status of this recall?

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

Source: FDA — FDA Recall D-0752-2026: SEMAGLUTIDE 0.9mg (0.9 mg/mL), 1 mL Sterile Multi-Dose Vial, Rx Only, For Subcut · 2026-08-19