Apollo Care, LLC recalls SEMAGLUTIDE 2.25MG (0.9 mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care,

What was recalled

The U.S. Food and Drug Administration (FDA) has issued a Class II recall affecting a specific batch of prescription medication distributed by Apollo Care, LLC. This is not a vague warning about an entire brand line; it targets precise vials of Semaglutide that were manufactured and distributed under the Apollo Care label. If you or someone in your household uses this particular diabetes or weight management treatment, it is vital to check your medicine cabinet against the details below to see if your specific product is part of this recall.

The recalled item is the SEMAGLUTIDE 2.25MG (0.9 mg/mL) Sterile Multi-Dose Vial. These are prescription-only medications intended for subcutaneous injection, meaning they are designed to be injected just under the skin. Each vial contains 2.5 mL of the sterile solution. The product is identified by the National Drug Code (NDC) 71170-811-02. It is important to note that this recall does not necessarily affect every single vial Apollo Care has ever produced, but rather those associated with specific lot numbers and expiration dates.

The affected lots are clearly marked on the packaging. You should look for Lot number AC-017114, which has an expiration date of November 24, 2026. Additionally, the recall includes vials from lots AC-017164, AC-017204, and AC-017205, all of which carry an expiration date of December 31, 2026. If your vial matches any of these lot numbers and expiration dates, it is part of this specific recall action.

Apollo Care, LLC is located at 3801 Mojave Ct, Ste 102, Columbia, MO 65202. The company distributed these recalled products nationwide within the United States. This means that while the manufacturing or distribution hub is in Missouri, the affected vials could be in pharmacies or patient homes across all 50 states. Because the distribution was national, there is no geographic region that is automatically safe from having received this product. Patients who have recently filled a prescription for Semaglutide from Apollo Care should verify their lot numbers immediately, as the recall date was announced on July 29, 2026.

The hazard, explained

When the FDA issued this recall for Apollo Care’s Semaglutide vials, the core issue wasn’t about the drug’s chemical composition failing to work as intended, but rather about physical contamination within a sterile environment. Specifically, inspectors identified the presence of particulate matter inside the multi-dose vials. These particles were described as having the characteristics of nylon/polyamide and silk/proteinaceous materials. To understand why this is dangerous, it helps to look at what happens when you inject a solution that contains solid foreign objects.

Semaglutide is administered via subcutaneous injection, meaning the medication is delivered directly into the fatty tissue just beneath the skin. While the drug itself is designed to be absorbed gradually by the body, any solid particle introduced into this tissue becomes an unwanted intruder. Nylon and polyamide are synthetic polymers often found in manufacturing equipment, filters, or packaging components. Silk-like proteinaceous material can originate from biological sources or certain types of filtration media. When these materials break off or migrate into the vial during the manufacturing or filling process, they remain suspended in the liquid. Unlike a dissolved drug molecule, which is invisible and interacts chemically with your body’s receptors, these particles are macroscopic physical entities.

The primary mechanism of harm here is mechanical irritation and potential blockage. When you draw the medication from the vial to inject it, you may inadvertently pull one or more of these particles into the syringe needle. Because needles used for subcutaneous injections are very fine, larger particles can sometimes clog the needle entirely, leading to incomplete dosing or difficulty administering the medication. More critically, if the particle passes through the needle tip and enters your tissue, it acts as a foreign body. Your immune system recognizes this material as an invader and launches an inflammatory response around it. This can result in localized pain, swelling, redness, and the formation of granulomas—small areas of inflammation that can persist for weeks or months.

Furthermore, there is a risk of embolization, though less common with subcutaneous than intravenous routes. If a particle were to enter a small blood vessel near the injection site, it could travel through the bloodstream. While the body typically filters out larger particles in the lungs or liver, any foreign material circulating in the blood carries a risk of triggering clotting responses or blocking tiny capillaries. This is why sterility and particulate-free solutions are non-negotiable standards for injectable drugs. The presence of nylon or proteinaceous debris suggests a failure in the quality control process, likely involving filtration systems, vial sealing equipment, or handling procedures that allowed synthetic fibers or organic matter to breach the sterile barrier. For a patient relying on consistent, safe delivery of a GLP-1 agonist like Semaglutide, this physical contamination introduces an unpredictable variable into what should be a controlled therapeutic process.

Who is most at risk

To understand who is most vulnerable in this specific recall, we first need to look at the nature of the product itself. Semaglutide, manufactured by Apollo Care, LLC under the brand name Apollo Care, is not a typical over-the-counter medication you might keep in a bathroom cabinet for occasional use. It is a prescription-only drug designed for subcutaneous injection, meaning it must be administered directly into the fatty tissue just beneath the skin. This classification immediately narrows the pool of potentially affected individuals to those who have been formally diagnosed with conditions such as type 2 diabetes or obesity by a licensed healthcare provider and have subsequently received a valid prescription. Because the product is available in a sterile multi-dose vial, it is intended for repeated use over time, which means the risk exposure extends beyond a single moment of administration to anyone who has filled this specific prescription since the manufacturing date and continues to store or prepare doses from these vials.

The primary hazard identified in this Class II recall is the presence of particulate matter within the solution. The FDA investigation determined that these particles are composed of nylon/polyamide and silk/proteinaceous-type materials. While a single microscopic particle might seem insignificant, introducing foreign solid matter directly into the human body via injection carries inherent physiological risks that do not apply to oral medications. For the average healthy adult, the immune system may sometimes handle minor particulate exposure without immediate catastrophic failure, but this is not a guarantee of safety. The real concern lies in how these particles interact with the bloodstream and vascular system once they bypass the skin’s natural barrier. If a particle enters a blood vessel, it can potentially travel to smaller capillaries, leading to embolisms or localized tissue damage, depending on where it settles.

Certain demographic groups face heightened vulnerability when dealing with injectable medications containing particulate contaminants. Individuals with compromised immune systems, such as those undergoing chemotherapy or managing autoimmune disorders, may find their bodies less capable of filtering out or responding to these foreign materials effectively. Similarly, patients with existing cardiovascular conditions are at greater risk because the introduction of particulates can interfere with blood flow in delicate vascular networks. Elderly patients, who often have thinner skin and more fragile blood vessels, may also experience increased difficulty in managing local injection site reactions or systemic responses to contaminants. Furthermore, because semaglutide affects glucose metabolism and gastric emptying, any physiological stress introduced by particulate matter could potentially complicate the management of underlying metabolic conditions, leading to unpredictable health outcomes.

It is also important to consider the practical aspects of who handles this medication. While the patient is the ultimate recipient of the drug, caregivers, family members, or nursing staff who assist with injections are not immune to risk if they handle contaminated vials without proper protection, though their primary risk would be exposure rather than systemic injection. The recall affects units distributed nationwide within the U.S., meaning that anyone who has obtained this specific product from pharmacies across all states is potentially in the affected group. However, the risk is strictly limited to those holding the specific lots identified: AC-017114 (expiring 11/24/2026) and lots AC-017164, AC-017204, and AC-017205 (expiring 12/31/2026). If you do not possess these exact lot numbers, your risk profile is effectively zero regarding this specific recall event.

How to tell if you have the recalled item

Before taking any action, it is crucial to verify whether your specific vial of Semaglutide is part of this recall. Because pharmaceutical recalls often target very specific batches rather than an entire product line manufactured over several years, simply having a bottle from Apollo Care is not enough to confirm you are affected. You must examine the physical packaging and the vial label for exact matches against the official data provided by the Food and Drug Administration. The first thing you should look for is the brand name clearly printed on the box or label: it must say Apollo Care. If your medication was purchased under a different manufacturer’s name, even if it is also semaglutide, it is not part of this specific recall.

Next, you need to verify the strength and concentration. The recalled item is specifically SEMAGLUTIDE 2.25MG (0.9 mg/mL). It comes in a 2.5 mL Sterile Multi-Dose Vial. This is an important distinction because semaglutide often comes in pre-filled pens or different vial concentrations (such as 1.34 mg/mL). If your vial has a different volume or concentration, it is not included in this notice. Additionally, check the route of administration indicated on the label; the recalled product is marked Rx Only and is intended For Subcutaneous Injection Only.

The most critical step is to match the National Drug Code (NDC) and the Lot numbers. Locate the NDC on your packaging or vial. The recalled product has the NDC 71170-811-02. If this number does not match exactly, your item is safe from this specific recall. Following that, you must check the Lot number and expiration date. There are two distinct groups of lots included in this recall:

• Group 1: Lot AC-017114 with an expiration date of 11/24/2026.
• Group 2: Lots AC-017164, AC-017204, and AC-017205, all with an expiration date of 12/31/2026.

If your vial’s lot number falls outside of these five specific codes, or if the expiration date does not align with the dates listed above for those particular lots, you do not have a recalled item. The manufacturer associated with this recall is Apollo Care, LLC, located at 3801 Mojave Ct, Ste 102, Columbia, MO 65202. While the distribution was nationwide within the U.S., knowing the manufacturer helps confirm authenticity. Please note that the recall announcement date for this issue is 2026-07-29. If you cannot find these exact details on your vial or packaging, it is highly likely your medication is not part of this batch. When in doubt, do not guess; contact your pharmacy or healthcare provider with the numbers from your label for confirmation.

What to do — step by step

If you or a family member have been prescribed this specific batch of semaglutide from Apollo Care, LLC, the most important immediate action is to stop using the medication right away. Because the recall involves the presence of particulate matter—specifically identified as nylon/polyamide and silk/proteinaceous-type material—injected directly into your body via subcutaneous injection, continuing to use these vials poses a significant risk. These foreign particles can cause inflammation, block blood flow locally at the injection site, or potentially travel through the bloodstream to other organs, leading to serious complications such as embolisms or severe allergic reactions. Do not wait for symptoms to appear before taking action; prevention is critical when dealing with contaminated injectable drugs.

The next step is to carefully inspect any remaining vials you possess. Look closely at the liquid inside the 2.5 mL Sterile Multi-Dose Vials. While particulate matter may not always be visible to the naked eye, any cloudiness, discoloration, or floating specks are clear signs of contamination. However, even if the solution looks perfectly clear, you must assume it is unsafe if it matches one of the recalled lot numbers: AC-017114 (Exp. 11/24/2026), AC-017164, AC-017204, or AC-017205 (all Exp. 12/31/2026). Keep the vials in their original packaging if possible, as this helps preserve the lot information and NDC number (71170-811-02) for verification.

Regarding the official remedy or return process, the FDA recall facts currently do not specify a detailed procedure for returning the product or obtaining a refund. This is a critical gap in the public guidance, so you cannot rely on standard return instructions that might apply to other recalls. Instead, you must take proactive steps to resolve this. Contact your prescribing physician or healthcare provider immediately to inform them of the recall and to discuss alternative treatment options. They can help ensure you do not miss doses of your medication while you seek a replacement from a different manufacturer or supply chain.

You should also contact Apollo Care, LLC directly to inquire about their specific return and reimbursement policies. Their address is listed as 3801 Mojave Ct, Ste 102, Columbia, MO 65202. Ask them explicitly how they plan to handle the Class II recall for these specific lots. Since the remedy is not stated in the federal report, the company may have issued a separate customer notice or updated their website with instructions that are not yet reflected in this summary. Request written confirmation of any return shipping labels or refund procedures they provide.

If you experience any adverse health effects after using these vials, such as pain at the injection site, swelling, redness, fever, or difficulty breathing, seek medical attention immediately. Tell your healthcare provider that you used a recalled Apollo Care semaglutide product containing potential particulate matter. Keep all documentation related to this recall, including photos of the vial labels and any correspondence with the manufacturer or pharmacy, in case you need to file an insurance claim or pursue further action later.

Your refund, repair, or replacement options

When you encounter a recall notice for a prescription medication like the Semaglutide vials distributed by Apollo Care, LLC, it is completely natural to feel anxious about how to proceed with the product in your possession. The first and most important thing to understand is that the remedy for this specific Class II recall has not been explicitly stated in the official FDA report. This absence of a prescribed return or replacement protocol is actually quite common in pharmaceutical recalls involving particulate matter, and it reflects standard industry safety practices rather than an oversight on the part of regulators or the manufacturer.

In cases where the remedy is not publicly detailed, you should not attempt to return the product to a retail store or mail it back to the company without specific instructions. Pharmaceutical products are considered hazardous waste in many jurisdictions once they leave the controlled supply chain. Sending them through standard mail or dropping them off at a generic pharmacy counter can pose safety risks to postal workers, pharmacists, and the environment. Furthermore, because this recall involves the presence of foreign particulate matter—specifically identified as nylon/polyamide and silk/proteinaceous-type material—the integrity of the vial is compromised. There is no "repair" possible for a sterile multi-dose vial that has been contaminated during manufacturing or packaging. The product cannot be cleaned, filtered, or made safe for use again.

Instead of seeking a refund or replacement through a standard consumer return process, your primary course of action is to consult the healthcare professional who prescribed this medication. Your doctor or pharmacist acts as your bridge to the manufacturer’s internal recall management team. They have access to proprietary customer service channels and direct lines to Apollo Care, LLC that are not typically advertised in public news releases. When you contact your provider, explain that you have a vial with NDC 71170-811-02 from lots AC-017114, AC-017164, AC-017204, or AC-017205. They can verify if your specific lot is part of the current recall scope and guide you on how to obtain a replacement prescription without interruption in your treatment.

Regarding financial restitution, because the remedy is not stated, you will need to rely on your insurance provider’s coverage policies for recalled products. Most health insurance plans in the United States have provisions that cover the cost of replacing a medication that has been recalled due to safety concerns. Your pharmacist can often process this as an administrative override or a special claim, ensuring that you do not bear the out-of-pocket cost for the defective vial. If you are paying cash, keep all receipts and documentation of the recall notice. While Apollo Care, LLC has not published a direct refund address, they may handle financial claims through their legal or quality assurance departments directly upon request from your healthcare provider.

It is crucial to dispose of the recalled vial safely. Do not flush it down the toilet or throw it in the household trash where it could be accessed by children or pets. Your pharmacist can direct you to a local drug take-back program, which is the safest and most environmentally responsible way to destroy the product. By following these steps—contacting your prescriber, utilizing insurance coverage for replacement, and disposing of the item safely—you protect your health while navigating the administrative gaps left by an unstated remedy.

What can happen if you ignore it

Staying safe: broader tips

When dealing with prescription medications like semaglutide, particularly those administered via injection, your safety relies heavily on maintaining the integrity of the drug from the moment it leaves the pharmacy until it enters your body. While recalls are essential tools for correcting manufacturing errors, they are reactive measures. Proactive vigilance is your best defense against potential hazards such as particulate contamination, which can occur due to packaging defects or handling issues. One of the most effective ways to ensure you are receiving safe medication is to verify its authenticity and condition before use. Always inspect vials and pens for any signs of tampering, cracks in the glass, or unusual cloudiness. If a solution appears cloudy when it should be clear, or if you see visible specks or fibers floating within the liquid, do not use it. These visual cues are often the first indication that particulate matter may be present, which could pose serious health risks if injected into the bloodstream or subcutaneous tissue.

Proper storage is another critical component of medication safety that many people overlook. Semaglutide and similar biologics are sensitive to temperature fluctuations. Storing your medication outside of the recommended range—whether in a car during summer heat or near a kitchen window where temperatures vary significantly—can degrade the drug’s stability. This degradation can lead to the formation of aggregates or other particulate-like structures that might not be immediately obvious but could alter the drug’s efficacy or safety profile. Always follow the specific storage instructions provided by your pharmacist, typically requiring refrigeration at 36°F to 46°F (2°C to 8°C) before first use, and room temperature storage after opening, depending on the manufacturer’s guidelines. Never freeze semaglutide, as freezing can damage the protein structure of the drug.

Furthermore, stay informed about ongoing safety communications from regulatory bodies like the FDA and your healthcare provider. Sign up for email alerts on recalls.gov or download official apps that notify you of new safety warnings. This habit ensures that you are not caught off guard by sudden recalls affecting medications you currently use or may be prescribed in the future. Additionally, maintain an open line of communication with your doctor or pharmacist. If you experience any unexpected side effects after using a medication, report them immediately. Your feedback contributes to the broader safety monitoring system and helps protect others who might use the same batch. By combining careful inspection, proper storage, and proactive information gathering, you create a robust personal safety net that complements the work of regulatory agencies.

Finally, consider the hygiene aspects of your injection routine. While not directly related to manufacturing defects, improper handling can introduce contaminants. Always wash your hands thoroughly before preparing an injection, use sterile alcohol swabs on the vial’s rubber stopper, and never share needles or pens with others. These simple steps reduce the risk of infection and ensure that the medication you administer remains as pure and effective as possible. Remember, safety is a shared responsibility between manufacturers, regulators, and consumers. By staying informed and careful, you play a vital role in your own health protection.