Apollo Care, LLC recalls SEMAGLUTIDE 20mg (5mg/mL), Glycine 20 mg (5mg/mL), 4 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection

What was recalled

The U.S. Food and Drug Administration (FDA) has issued a Class II recall involving a specific pharmaceutical product distributed by Apollo Care, LLC. This action centers on the SEMAGLUTIDE 20mg (5mg/mL) combined with Glycine 20 mg (5mg/mL), presented in a 4 mL sterile multi-dose vial intended for subcutaneous injection only. These are prescription-only medications, meaning they are not available over the counter and require a healthcare provider’s authorization to obtain. The manufacturer listed on the recall notice is Apollo Care, located at 3801 Mojave Ct, Ste 102, Columbia, MO 65202. It is important to note that this recall was initiated on July 29, 2026, and affects products distributed nationwide within the United States.

To accurately identify whether you possess the affected inventory, you must look for specific details printed on the packaging and vials. The product carries the National Drug Code (NDC) number 71170-724-04. The recall is not blanket across all Apollo Care products but is strictly limited to three specific lot numbers: AC-017275, AC-017282, and AC-017285. Each of these lots has a defined expiration date. Lots AC-017282 and AC-017285 are scheduled to expire on December 27, 2026, while lot AC-017275 has an earlier expiration date of December 13, 2026. If your vial does not match both the NDC number and one of these three lot numbers with the corresponding expiration dates, it is not part of this specific recall.

The classification of this recall as a Class II event indicates that use or exposure to the defective product might cause temporary health problems or pose a slight threat of a serious nature. However, in terms of physical units, the official FDA recall record does not specify the exact number of vials or packages distributed or recalled. The distribution pattern is described simply as nationwide within the U.S., meaning these products could be found in pharmacies, clinics, or healthcare facilities across all fifty states. Because the specific quantity of units is not stated in the public record, individuals relying on this information should contact Apollo Care directly or consult their prescribing physician for further details regarding the scope of distribution if necessary.

Understanding exactly what was recalled helps prevent unnecessary panic while ensuring that those who might be affected can take appropriate steps. The product in question is a specific formulation of semaglutide, a medication often used for managing blood sugar levels and weight loss, compounded with glycine. The precise identification of the brand, the exact chemical concentrations (20mg of semaglutide and 20mg of glycine per 4mL vial), and the manufacturer’s address are critical for verifying authenticity. Without these specific identifiers, it is impossible to determine if a product falls under this FDA alert. Therefore, checking the lot number against the list provided by the agency is the most reliable method of confirmation.

The hazard, explained

When the FDA issued this recall for Apollo Care’s semaglutide product, they identified a very specific physical problem: the presence of particulate matter inside the vials. To understand why this is serious, it helps to look at what “particulate matter” actually means in the context of an injectable drug. Ideally, a sterile multi-dose vial like the one recalled should contain only a clear, uniform liquid solution. Instead, inspections revealed foreign particles that have been identified as nylon/polyamide and silk/proteinaceous-type material. These are not microscopic impurities that dissolve or blend in; they are tangible, solid fragments suspended within the medication.

The mechanism of harm here is direct physical introduction. When a patient draws medication from this vial to administer a subcutaneous injection, these particles travel through the needle and enter the body along with the drug. Because the material includes nylon (a synthetic polymer) and silk/proteinaceous matter, the body does not recognize these as benign substances. Instead, they are treated as foreign invaders. This can trigger an immediate inflammatory response at the injection site, leading to redness, swelling, pain, or tissue irritation that goes beyond typical minor needle trauma. In some cases, depending on the size and shape of the particles, this can cause localized tissue damage or necrosis (tissue death) where the injection was given.

Beyond the immediate local reaction, there is a risk of systemic complications. If these particulates are small enough to enter the bloodstream rather than staying in the subcutaneous tissue, they can travel through the circulatory system. While the body’s immune system attempts to filter out such debris, it cannot always do so completely. This can lead to granuloma formation (clusters of immune cells trying to wall off the foreign material) or, in rare but severe cases, embolisms where particles block small blood vessels in vital organs like the lungs or heart. Even if systemic blockage does not occur, the presence of non-sterile organic matter like silk proteins raises the specter of infection. These materials can carry microbial loads or serve as a scaffold for bacteria to grow, potentially leading to serious infections such as abscesses or sepsis if the body’s defenses are overwhelmed.

It is also important to consider the integrity of the drug itself. The presence of nylon and proteinaceous debris suggests a failure in the manufacturing or packaging process, possibly involving filter degradation or contamination from equipment components. This raises questions about whether the semaglutide potency remains accurate. If the solution has been compromised by foreign materials, the therapeutic effect may be unpredictable, leaving patients with uncontrolled blood sugar levels without them realizing the medication is faulty. For a drug used to manage chronic conditions like diabetes, this unpredictability adds a layer of metabolic risk on top of the physical risks described above.

Who is most at risk

To understand who is most vulnerable in this specific recall, we first need to look closely at what is being recalled. The FDA has identified a Class II recall involving Semaglutide 20mg (5mg/mL) combined with Glycine 20 mg (5mg/mL), distributed by Apollo Care, LLC from Columbia, Missouri. This medication is prescribed for subcutaneous injection, meaning it is delivered directly into the fatty tissue just under the skin. Because this is a prescription-only drug intended for specific medical management, the primary group at risk is anyone who has been prescribed this particular formulation by their healthcare provider and has received vials from the affected lots: AC-017275, AC-017282, or AC-017285. These patients are not just passive consumers; they are actively handling a sterile injectable product that has been compromised.

The specific hazard here—the presence of particulate matter described as nylon/polyamide and silk/proteinaceous-type material—creates a unique set of risks that extend beyond the typical side effects of semaglutide. For the average adult user, the immediate danger is localized. If a patient injects this solution without seeing visible particles (which can be difficult in a multi-dose vial), those foreign substances enter their bloodstream or subcutaneous tissue. This can lead to local inflammatory reactions, such as severe redness, swelling, or pain at the injection site. However, the risk escalates significantly for individuals with compromised immune systems. For patients already managing chronic conditions that require semaglutide, their bodies may be less equipped to handle the additional stress of an immune response triggered by foreign particulates.

Elderly patients and those with underlying vascular or circulatory issues face heightened dangers. When particulate matter enters the bloodstream, it can potentially travel to smaller blood vessels. In healthy individuals, the body might filter out small debris, but in older adults or those with pre-existing conditions like diabetes-related vascular complications (a common reason for prescribing semaglutide), these particles can cause micro-embolisms or block tiny capillaries. This could lead to tissue damage or impaired healing at the injection site and beyond. Furthermore, because this is a sterile multi-dose vial, the risk is not limited to a single dose. If the contamination occurred during the manufacturing process, every subsequent use of that vial exposes the patient to the same hazard, increasing the cumulative load of particulates in their body over time.

Additionally, individuals who are visually impaired or have difficulty distinguishing subtle changes in liquid clarity may be at greater risk. The recalled vials contain sterile solutions where particulate matter might not always be immediately obvious to the naked eye, especially if the particles are microscopic or suspended in a way that mimics normal protein structures. Without careful inspection under proper lighting, these users might unknowingly administer the contaminated drug. Therefore, the most at-risk population includes patients who rely on this medication for serious metabolic conditions, those with limited dexterity or vision that makes product inspection difficult, and anyone with weakened physiological defenses against foreign material. It is crucial for these individuals to stop using the affected lots immediately and consult their healthcare provider to discuss safe alternatives and necessary monitoring.

How to tell if you have the recalled item

Before taking any action or contacting a healthcare provider, it is essential to verify whether your medication is part of this specific recall from Apollo Care, LLC. Because pharmaceutical recalls are often limited to precise batches and lot numbers, simply having "Semaglutide" on hand does not automatically mean your product is affected. You must check the physical packaging against the official details provided by the FDA. The primary identifier you need to locate is the National Drug Code (NDC), which serves as a unique three-segment number assigned to each drug listing. For this recall, the NDC is 71170-724-04. If your vial does not bear this exact code, it is not part of this specific safety notice.

In addition to the NDC, you must carefully inspect the lot number and the expiration date printed on the label. This recall covers three specific lots, all of which share a similar manufacturing prefix but have distinct suffixes and expiry dates. Please look for any of the following lot numbers on your vial: AC-017275, AC-017282, or AC-017285. If you find one of these codes, check the expiration date to confirm it matches the corresponding date listed in the recall notice. The lot AC-017275 is expired on 12/13/2026, while lots AC-017282 and AC-017285 are set to expire on 12/27/2026. It is crucial to note that the product description specifies these items as "Semaglutide 20mg (5mg/mL)" combined with "Glycine 20 mg (5mg/mL)" in a "4 mL Sterile Multi-Dose Vial." Ensure that the concentration and volume match these specifications exactly, as different strengths or volumes may be produced under different codes not included in this recall.

You should also verify the manufacturer information on the box or vial label. The product must be identified as coming from "Apollo Care" located at 3801 Mojave Ct, Ste 102, Columbia, MO 65202. While the distribution of this recall is nationwide within the United States, meaning it could have been sold in any state, the source of the product must align with these details. If your medication was obtained from a different pharmacy, compounding facility, or manufacturer, or if the lot numbers do not match the list above, your product is likely safe and not subject to this specific recall action. Do not rely on general descriptions alone; the lot number is the most definitive way to confirm whether your item is affected.

What to do — step by step

Your refund, repair, or replacement options

When you receive news of a drug recall, the immediate concern is often how to resolve the situation without incurring additional costs or facing health risks. In this specific instance involving Apollo Care, LLC’s recalled Semaglutide products, it is important to address the remedy with clarity and honesty. The official FDA recall documentation for this Class II recall does not explicitly state a predefined remedy such as a refund, repair, or replacement program in the public notice. This absence of stated terms can feel uncertain, but it does not mean you are left without options or that the company is ignoring its responsibilities. Instead, it highlights the critical need for you to take proactive steps to initiate any potential resolution directly with the responsible party.

Because the recall notice lacks specific instructions on how to claim a refund or receive a replacement vial, your primary course of action must be to contact Apollo Care, LLC directly. The company is located at 3801 Mojave Ct, Ste 102, Columbia, MO 65202. While the public recall text does not provide a dedicated phone number or email address for customer service regarding this specific lot, you should attempt to reach their general business office using publicly available contact information for Apollo Care in Columbia, Missouri. When you make contact, be prepared to provide the specific details of your product to expedite the process. This includes the National Drug Code (NDC) 71170-724-04 and the specific lot numbers: AC-017275 (expiring 12/13/2026), AC-017282, or AC-017285 (both expiring 12/27/2026). Having this information ready will demonstrate that you have identified the exact product in question and help the company verify your eligibility for any potential restitution.

It is also vital to understand why a remedy might not be explicitly listed in the initial recall alert. Class II recalls, like this one, are issued when the use of a violative product may cause temporary or medically reversible health consequences. The hazard here—particulate matter identified as nylon/polyamide and silk/proteinaceous material—is a serious quality control failure that necessitates immediate removal from the market. However, the logistical process of organizing returns, refunds, or replacements can sometimes lag behind the initial regulatory announcement. Therefore, do not assume that no remedy exists simply because it is not printed in the federal notice. Manufacturers are generally required by the FDA to develop and submit a recall strategy, which often includes compensation for consumers who purchased the affected lots. Your engagement with Apollo Care is the key to unlocking this process.

If you are unable to reach Apollo Care directly through their physical address or general lines, consider reaching out to your healthcare provider or pharmacist who dispensed the medication. They may have received direct communication from the manufacturer regarding return procedures or may be able to assist in facilitating a replacement prescription with a different lot number that has passed quality controls. Additionally, you can monitor the FDA’s official website for updates to this specific recall notice, as remedy details are often added to public alerts after the initial classification is made. Until then, your best path forward is persistent, documented communication with Apollo Care, LLC, clearly stating your request for a refund or replacement due to the safety hazard of particulate contamination.

What can happen if you ignore it

When a pharmaceutical product carries a Class II recall classification from the FDA, it signals a situation that is serious but not immediately life-threatening in the vast majority of cases. However, "serious" does not mean "harmless." If you continue to use the recalled Apollo Care Semaglutide vials after this notice has been issued, you are introducing an unnecessary and uncontrolled variable into your medical treatment. The primary hazard identified is the presence of particulate matter—specifically materials described as nylon/polyamide and silk/proteinaceous-type substances—within a sterile solution intended for subcutaneous injection. Ignoring this defect means ignoring the potential for these foreign particles to travel with the medication into your body.

The most immediate physical risk involves the site of injection. When you administer a drug containing visible or microscopic particulates, those particles can cause local tissue irritation, inflammation, or granuloma formation at the injection site. Granulomas are small areas of inflammation that form when the immune system attempts to wall off foreign material it cannot eliminate. This can lead to persistent pain, redness, swelling, or hard lumps under the skin where you injected the medication. For individuals managing chronic conditions like diabetes or obesity with Semaglutide, such localized reactions can complicate your care routine, cause significant discomfort, and potentially lead to secondary infections if the skin barrier is compromised by repeated irritation.

Beyond local tissue reaction, there is a broader concern regarding systemic safety. While subcutaneous injections generally bypass some of the immediate filtration that occurs in the lungs or liver, introducing non-sterile or unexpected particulate matter into your bloodstream carries risks that are difficult to predict. Proteinaceous materials (like silk) can trigger immune responses in sensitive individuals, potentially leading to allergic reactions ranging from mild rashes to more severe anaphylaxis, though such outcomes depend heavily on individual immune history. Furthermore, the presence of foreign material suggests a breakdown in the manufacturing quality control process. If particulates are present, it raises questions about the sterility of the vial itself and whether other unseen contaminants might also be present. Continuing to use this product undermines the safety protocols designed to keep injectable drugs pure and safe.

There is also the practical consequence of compromised treatment efficacy. If the drug formulation is altered by contamination, the concentration of Semaglutide may not be as reliable as stated on the label. This could mean you are receiving less medication than prescribed, leading to poor management of your underlying health condition. In a worst-case scenario, inconsistent dosing can cause blood sugar levels or other metabolic markers to fluctuate unpredictably, which is dangerous for anyone relying on this medication for stability. The FDA’s classification as Class II indicates that use of the product could cause temporary medical harm or serious injury if the defect were to manifest clinically. By ignoring the recall, you are essentially gambling with your health, assuming that the defective batch will not affect you personally—a risk that is entirely avoidable by following the recall instructions.

Staying safe: broader tips

When dealing with injectable medications, particularly those compounded or sourced from specialized pharmacies like Apollo Care, maintaining a vigilant approach to storage and handling is your first line of defense against contamination. The hazard identified in this recall—particulate matter such as nylon or silk fibers—often stems from issues within the manufacturing environment, packaging integrity, or the sterile technique used during compounding. While you cannot control how these items are made, you can significantly reduce risk by strictly adhering to proper storage conditions. Most semaglutide formulations require refrigeration between 36°F and 46°F (2°C to 8°C) prior to first use. Exposure to temperature fluctuations can degrade the stability of the solution, potentially leading to precipitation or other chemical changes that mimic particulate hazards. Always keep vials in their original boxes until you are ready to use them, as the packaging provides an additional layer of protection against light and physical damage.

Before administering any injectable medication, perform a thorough visual inspection every single time. Hold the vial up to a light source at eye level and look closely at the liquid. It should be clear and colorless. If you see any cloudiness, discoloration, or floating particles—no matter how small—do not use it. This is non-negotiable for multi-dose vials as well. Because these vials allow for multiple entries, the risk of introducing contaminants increases with each puncture of the stopper. Always use a new, sterile needle and syringe for every injection. Never share needles or syringes with anyone else, and never reuse a needle that has already been used, as this can compromise sterility and introduce skin bacteria into the solution.

It is also crucial to stay informed about regulatory updates beyond just one specific recall. The FDA maintains a public database of all drug recalls, classified by severity (Class I being the most urgent). Setting up alerts for your medication class or regularly checking the FDA’s website can help you catch issues early. Additionally, verify that any compounding pharmacy you use is accredited by organizations like the Pharmacy Compounding Accreditation Board (PCAB) and operates under strict Good Manufacturing Practices. If a pharmacy cannot provide clear documentation of their sterile processing protocols or if they seem evasive about their sourcing, it may be wise to seek care elsewhere. Your health is too important to rely on guesswork when it comes to injectable therapies.

• Store all refrigerated medications in the main body of the fridge, not the door, to ensure consistent temperatures.
• Inspect every dose visually before drawing it up; discard any vial with particulates or discoloration immediately.
• Use sterile, single-use needles for every injection to prevent cross-contamination and infection.
• Monitor your medication supply regularly against FDA recall lists to ensure you are using safe, unrecalled batches.