What was recalled
The U.S. Food and Drug Administration recently issued a Class II recall involving a specific prescription medication manufactured by Apollo Care, LLC. This action centers on Sterile Multi-Dose Vials of Semaglutide 12.5mg (which equates to a concentration of 2.5mg/mL), packaged in 5 mL vials intended strictly for subcutaneous injection. Because this is an Rx-only product, it is not available over-the-counter; it is dispensed directly to patients through pharmacies based on a healthcare provider’s prescription. The recall was initiated on July 29, 2026, and affects products distributed nationwide across the United States, with the manufacturer’s operations located in Columbia, Missouri.
To help you determine if your medication is part of this specific batch, it is crucial to look at the National Drug Code (NDC) and the lot numbers printed on the packaging. The recalled items bear NDC 71170-495-05. However, the NDC alone does not identify the problem; you must check the expiration date and the specific lot code stamped on the box or vial. Apollo Care has identified several distinct lots as part of this recall, all sharing a common manufacturing origin but differing in their expiry timelines. The affected lot numbers include AC-017108, which expires on November 17, 2026, and AC-017110, expiring on November 20, 2026.
The recall extends further into late 2026 with two additional groups of lots. One group includes lots AC-017112 (expiring November 21, 2026), as well as AC-017142 and AC-017144 (both expiring December 10, 2026). A final, larger set of lots comprises AC-017166, AC-017167, AC-017177, AC-017213, AC-017224, and AC-017225, all of which are scheduled to expire on December 31, 2026. If you have any of these specific lot numbers in your possession, the product is subject to this recall.
It is important to understand that a Class II recall indicates a situation where use of the product may cause temporary or medically reversible health consequences, or where the probability of serious adverse effects is remote. While the remedy for this specific recall has not been explicitly detailed in the initial FDA report, the presence of particulate matter in a sterile injectable drug is a significant quality control issue. Manufacturers like Apollo Care, located at 3801 Mojave Ct, Ste 102, Columbia, MO 65202, typically initiate such recalls when internal testing or external reports reveal contamination that falls outside strict safety standards. This recall underscores the rigorous monitoring required for compounded or specialty pharmaceuticals to ensure patient safety remains uncompromised.
The hazard, explained
When you look at a vial of Semaglutide from Apollo Care, LLC, it should appear as a clear, sterile solution designed for safe subcutaneous injection. However, this Class II recall identifies a critical physical failure: the presence of particulate matter within that liquid. The FDA’s investigation determined that these particles are composed of nylon/polyamide and silk/proteinaceous-type materials. In plain terms, this means that tiny, solid fragments—likely originating from manufacturing equipment such as filters or seals (nylon) or biological contaminants (silk/proteins)—have migrated into the medication itself. This is not a chemical change in the drug’s potency; rather, it is a physical contamination event where foreign solids are suspended in what should be a pure liquid.
The danger here lies in the method of administration. Semaglutide is administered via subcutaneous injection, meaning it is delivered directly into the fatty tissue just under the skin using a needle. Because these particles are microscopic but solid, they do not dissolve when injected. Instead, they travel through the needle and enter your body’s tissues. While the human immune system can sometimes handle very small amounts of debris, introducing foreign particulate matter via injection bypasses many of the body’s natural filtration systems. The primary physical harm comes from the potential for granuloma formation—a localized area of inflammation where the body walls off the foreign material with immune cells. This can lead to pain, swelling, redness, or hard lumps at the injection site that may persist long after the medication course is complete.
Beyond local tissue reaction, there is a more serious, albeit less common, risk if particles enter the bloodstream. If particulate matter is injected in sufficient quantity or size, it can travel through the circulatory system and lodge in small blood vessels. In the lungs, this can cause pulmonary granulomas or emboli; in other organs, it can trigger inflammation or block small capillaries. While a single vial may contain only a few visible particles, repeated use of contaminated stock increases the cumulative load of foreign material entering the body. This is why the FDA classifies this as a Class II recall: while not immediately life-threatening for most users, it poses a substantial risk of injury if left unaddressed. The "silk/proteinaceous" nature of some particles also raises concerns about allergic reactions or immune responses in sensitive individuals, as the body may recognize these proteins as foreign invaders.
It is important to understand that this hazard is invisible to the naked eye in many cases. Particulate matter can be clear and blend with the solution, making it impossible to detect without magnification or specialized lighting. This unpredictability is what makes recalls like this so vital—patients cannot rely on sight alone to ensure their medication is safe. The presence of these contaminants suggests a breakdown in sterile manufacturing controls, highlighting why rigorous quality assurance is essential for any drug intended for direct injection into the human body.
Who is most at risk
To understand who faces the greatest potential impact from this recall, it is helpful to first look at who typically uses this specific medication. The product in question is Semaglutide 12.5mg, a prescription drug primarily used to manage blood sugar levels in adults with type 2 diabetes and, increasingly, for weight management under strict medical supervision. Because this is a "Rx Only" medication, the individuals most directly involved are those who have been prescribed by a healthcare provider to inject this substance subcutaneously (under the skin). This demographic generally includes adults managing chronic metabolic conditions. However, the risk here is not about the drug’s intended therapeutic effect, but rather the physical contamination of the product itself.
The core hazard identified in this recall is the presence of particulate matter—specifically particles made of nylon/polyamide and silk/proteinaceous material—inside the sterile multi-dose vials. While a healthy adult might theoretically experience minor irritation from such particles, the individuals most at risk are those whose immune systems or physiological responses are more fragile. This includes elderly patients who may have comorbidities that complicate recovery from any adverse event. For older adults, even a localized reaction to an injection site can escalate into more serious complications due to thinner skin, slower healing times, or underlying vascular issues.
Furthermore, people with compromised immune systems are at heightened risk. Semaglutide is often prescribed to individuals who may also suffer from other conditions that require immunosuppressive therapies or who have diabetes-related complications that impair their body’s natural defense mechanisms. Introducing foreign particulate matter directly into the subcutaneous tissue bypasses the body’s first line of defense (the skin barrier). If these particles trigger an inflammatory response, a localized infection, or an allergic reaction, a person with a weakened immune system may struggle to clear the debris effectively. This could lead to abscesses, cellulitis, or systemic reactions that are far more severe than what a healthy individual might experience.
It is also important to note that because this is a multi-dose vial, the risk extends beyond just the first user. If any of the recalled lots (such as those expiring in November or December 2026) are kept in use, every subsequent injection carries the same potential hazard. Therefore, anyone sharing a household with a diabetic patient, or any caregiver administering these injections to others, is also at risk if they do not identify and discard the contaminated vials promptly. The danger lies in the unpredictability of how individual bodies react to unexpected foreign materials injected directly into tissue, making vigilance critical for all users regardless of their general health status.
How to tell if you have the recalled item
Before you take any action or contact a healthcare provider, it is essential to confirm that the specific vial in your possession matches the details of this FDA recall. Because pharmaceutical recalls are often tied to precise manufacturing batches rather than entire product lines, checking the exact lot number and expiration date is the only reliable way to determine if your medication is affected. Apollo Care, LLC has issued a Class II recall for their prescription drug SEMAGLUTIDE 12.5MG (2.5MG/mL). To verify whether you are impacted, you must carefully inspect the label on the 5 mL Sterile Multi-Dose Vial. Please note that this recall applies exclusively to the brand name "Apollo Care" and does not extend to semaglutide products manufactured by other companies.
The most critical piece of information on the packaging is the National Drug Code (NDC) and the Lot Number. You need to look for NDC 71170-495-05 printed clearly on the box or the vial label. If your vial has a different NDC, it is not part of this specific recall event. However, if the NDC matches, you must then check the Lot Number and the Expiration Date (Exp.). The recall covers several distinct lots with varying expiration dates. You are at risk if your vial bears any of the following lot numbers:
- Lot AC-017108, which expires on 11/17/2026.
- Lot AC-017110, which expires on 11/20/2026.
- Lot AC-017112, which expires on 11/21/2026.
- Lots AC-017142 and AC-017144, both of which expire on 12/10/2026.
- Lots AC-017166, AC-017167, AC-017177, AC-017213, AC-017224, and AC-017225, all of which expire on 12/31/2026.
If your vial does not list one of these specific lot numbers or if the expiration date is different from those listed above, your product is likely safe and not included in this recall. It is also helpful to know that these items were distributed nationwide within the United States, so the location where you purchased them does not help exclude them from the recall. The manufacturer’s address is listed as 3801 Mojave Ct, Ste 102, Columbia, MO 65202. Remember, this product is Rx Only and intended for subcutaneous injection only. Do not rely on the color or size of the box alone, as packaging can vary; always prioritize the printed NDC and Lot codes.
If you have found a match between your vial’s lot number and the list above, do not use the medication further until you have consulted with your pharmacist or healthcare provider. The presence of particulate matter, described in this recall as nylon/polyamide and silk/proteinaceous-type material, poses a serious health risk if injected. Your next step is to secure the vial safely so it is not accidentally administered to you or someone else, and then reach out to your prescription source for guidance on how to proceed with the remedy.
What to do — step by step
If you have been prescribed or currently possess Semaglutide from Apollo Care, LLC, particularly the 12.5 mg (2.5 mg/mL) sterile multi-dose vials, your immediate priority is to halt any further administration of this specific product. Because the recall stems from the presence of particulate matter—identified as nylon/polyamide and silk/proteinaceous material—injected directly into your body via subcutaneous injection, continuing to use these vials poses a direct risk of embolism, inflammation, or other serious adverse reactions. Please do not wait for symptoms to appear before taking action; prevention is the only safe path here.
First, carefully check your medication against the recall details provided by the FDA. Look at the NDC (National Drug Code) 71170-495-05 and verify the lot numbers. The affected lots include AC-017108, AC-017110, AC-017112, AC-017142, AC-017144, AC-017166, AC-017167, AC-017177, AC-017213, AC-017224, and AC-017225. Ensure you are looking at the expiration dates as well, which range from November 17, 2026, to December 31, 2026. If your vial matches these lot numbers, do not use it under any circumstances, even if the liquid appears clear to the naked eye, as particulate matter can be microscopic.
Next, you must contact your healthcare provider or pharmacist immediately. Inform them that you have a recalled vial in your possession. They will advise you on how to safely dispose of the product and, more importantly, how to obtain a replacement. Since the remedy for this specific recall has not been explicitly stated by Apollo Care, LLC or the FDA in the current data, do not assume a standard return-for-refund process is automatically set up. Your doctor may need to write a new prescription for a different manufacturer’s Semaglutide or a different lot that is confirmed safe.
Do not attempt to return the product to the store where you bought it unless your pharmacist specifically instructs you to do so, as pharmacy inventory protocols vary widely. Instead, follow your healthcare provider’s disposal instructions. This may involve using a FDA-approved sharps container and taking it to a designated drop-off site, or following local hazardous waste guidelines. If you experience any unusual symptoms after having used a vial from this lot, seek medical attention right away and mention the specific lot number to your care team.
Finally, stay informed. Check the FDA’s official website regularly for updates on this Class II recall. Manufacturers sometimes update remedy information as they investigate the root cause of the particulate contamination. Until further notice, treat all vials with NDC 71170-495-05 and the listed lot numbers as unsafe. Your health is too important to risk on uncertain data, so err on the side of caution and secure a verified safe alternative from your doctor.
Your refund, repair, or replacement options
When you receive a notification about a product recall, the immediate concern is often financial: "Will I get my money back?" or "How do I fix this problem without spending more out of pocket?" In the case of the recent Apollo Care, LLC recall involving Semaglutide 12.5mg sterile multi-dose vials, it is important to approach the remedy process with clarity and patience. The official FDA recall notice for this specific Class II issue does not explicitly outline a standardized consumer refund or replacement protocol in its public summary. This absence of detailed instructions might feel confusing, but it is actually quite common in pharmaceutical recalls where the primary focus is on immediate patient safety rather than transactional logistics. Because the remedy is "not stated" in the current recall data, you should not assume that a direct mail-in refund or an automatic replacement kit will arrive in your mailbox. Instead, the path to resolving this involves direct communication with the responsible parties who hold the records of your purchase. The first and most critical step is to identify where you obtained the medication. If you received these vials through a licensed pharmacy, your pharmacist is your primary point of contact. They have already begun or will begin the process of quarantining any remaining stock from Apollo Care, LLC on their shelves. For you as the patient, the remedy typically involves returning the unused portion of the recalled product to them. The pharmacy will then handle the logistics of sending the product back to the manufacturer or distributor for proper disposal and credit processing. They are equipped to verify your lot numbers against the recall list and can initiate a refund or issue a credit to your account for the cost of the medication. If you purchased the product directly from Apollo Care, LLC or through a specific online portal, you would need to contact their customer service department directly. However, since specific contact details such as phone numbers or email addresses are not provided in the current recall facts, you should look for the contact information listed on your original invoice, prescription label, or the company’s official website. It is also vital to understand that "repair" is not a viable option for this type of pharmaceutical product. You cannot clean particulate matter out of a sterile vial, nor can you safely reuse it. The remedy here is strictly about cessation and restitution. Do not attempt to sell or transfer the medication to friends or family; doing so could expose others to the same health risks associated with the nylon/polyamide contamination. If you have already used some of the vial before realizing the recall, do not panic, but do monitor your health closely for any unusual symptoms and consult your healthcare provider. Regarding financial compensation, while the recall notice does not specify a formal warranty or extended guarantee, standard consumer protection laws and pharmacy policies generally ensure that you are made whole for unused, defective goods. Keep all your receipts and packaging intact until you have successfully completed the return process with your pharmacy or the manufacturer. This documentation will be essential if any disputes arise regarding the refund amount or the validity of your claim. By staying in close contact with your healthcare provider and the dispensing pharmacy, you can navigate this situation smoothly and ensure that your health and financial interests are protected during this recall period.What can happen if you ignore it
When a pharmaceutical recall involves the presence of particulate matter, the primary concern shifts from the medication’s intended effect to the physical integrity of what is being injected into your body. In this specific case involving Apollo Care, LLC’s Semaglutide 12.5mg vials, the FDA identified foreign particles described as nylon/polyamide and silk/proteinaceous-type material. Ignoring this recall means continuing to administer a substance that contains microscopic, non-dissolvable solids. The consequences of doing so are not merely theoretical; they represent a direct violation of sterile injection safety principles and can lead to serious physiological complications.
The most immediate risk associated with injecting particulate matter is physical trauma to the vascular system or surrounding tissue. When you inject Semaglutide subcutaneously, the goal is for the medication to be absorbed slowly and safely through the fatty tissue. However, if particles such as nylon fragments or proteinaceous debris are present, they do not dissolve. Instead, they remain as foreign objects within your body. These particles can cause mechanical irritation at the injection site, leading to inflammation, pain, swelling, and potentially more severe local reactions like granulomas—small areas of inflammation that form when the immune system attempts to wall off substances it cannot eliminate.
Beyond local tissue damage, there is a significant risk of embolization. If these particles enter the bloodstream, even in microscopic quantities, they can travel through your circulatory system. While the body’s filtration systems in the lungs and liver are designed to catch such debris, an overload or larger-than-expected particles can obstruct small blood vessels. This blockage, known as an embolism, reduces blood flow to critical areas, which can lead to tissue damage or, in rare but severe cases, systemic complications. Although the recall notice does not report specific injuries at this time, the potential for such events is precisely why the FDA has classified this as a Class II recall, indicating that use of the product could cause temporary or medically significant adverse health consequences.
Furthermore, introducing foreign materials like nylon (a synthetic polymer) or silk proteins bypasses the body’s natural defenses. Your immune system will recognize these substances as invaders. This can trigger an inflammatory response that not only worsens local pain but may also lead to allergic reactions or hypersensitivity in susceptible individuals. For someone relying on Semaglutide for blood sugar management or weight control, dealing with unexpected inflammatory responses, injection site infections, or vascular complications can disrupt your overall health plan and require additional medical intervention. By ignoring the recall, you are essentially gambling with your body’s ability to process a sterile medication safely. The safest path is to stop use immediately and contact your healthcare provider to ensure that any potential exposure is monitored and managed appropriately.