What was recalled
The U.S. Food and Drug Administration (FDA) has issued a Class II recall involving a specific pharmaceutical product manufactured by American Regent, Inc., a company based in Shirley, New York. This action pertains to AMINAOCAPROIC ACID INJECTION, USP, a medication supplied at a concentration of 250 mg/mL. Specifically, the recall targets two distinct packaging configurations of this drug: first, individual 20 mL multiple-dose vials designed for intravenous (IV) infusion, identified by National Drug Code (NDC) number 0517-9120-01; and second, multi-packs containing twenty-five of these same 20 mL multiple-dose vials, identified by NDC number 0517-9120-25. It is important to note that this product is classified as prescription-only (Rx Only), meaning it is not available over the counter and must be dispensed under the direction of a licensed healthcare provider.
The scope of this recall is strictly limited to a single production lot to minimize disruption while ensuring patient safety. The affected inventory bears Lot number 24299, which carries an expiration date of August 31, 2026. This means that any AMINAOCAPROIC ACID INJECTION USP from other lots or with different expiration dates is not included in this specific recall notice. The distribution pattern for these recalled items covers the entire United States, indicating that hospitals, clinics, pharmacies, and healthcare facilities across all states may potentially possess this inventory. The recall was officially initiated on July 24, 2026, marking the date when American Regent, Inc., in coordination with the FDA, determined that corrective action was necessary due to safety concerns identified during quality control processes.
To help you identify whether you are holding a recalled item, please verify the following details against your physical inventory or records. The product must match all of the following criteria to be considered part of this recall: it is AMINAOCAPROIC ACID INJECTION, USP 250 mg/mL (5 g/20 mL); it is packaged in either a single 20 mL multiple-dose vial for IV infusion or a box of twenty-five such vials; the NDC is either 0517-9120-01 or 0517-9120-25; and the Lot number is exactly 24299. If any of these identifiers do not match, particularly if the lot number differs, your product is likely safe and unaffected by this specific recall event. American Regent, Inc., located at 11967 in Shirley, NY, is the responsible manufacturer associated with this distribution.
This recall is classified as a Class II recall by the FDA, which signifies a situation where use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. While the specific hazard details are covered in the next section, it is crucial to understand that this classification underscores the importance of prompt identification and removal of the affected lots from circulation. Healthcare providers should immediately check their storage areas for vials matching these exact specifications to ensure no doses are inadvertently administered to patients.
The hazard, explained
When a pharmaceutical product is recalled due to the presence of particulate matter, it means that tiny, unintended physical objects have made their way into what should be a sterile liquid solution. In this specific case involving American Regent’s Aminocaproic Acid Injection, the foreign materials identified include hair, glass, and paraformaldehyde. To understand why this is dangerous, we first need to look at how this medication is administered. Aminocaproic acid is an antifibrinolytic agent, which essentially means it helps stop bleeding by preventing the breakdown of blood clots. It is delivered directly into a patient’s bloodstream via intravenous (IV) infusion. Because it bypasses the body’s natural filtration systems—like the lungs and liver that might trap larger particles if a drug were taken orally—it travels unimpeded through the veins to the heart and then out to the rest of the body.
The physical danger here stems from the fact that these particulates are solid objects suspended in a fluid meant to be clear and homogeneous. When a vial contains hair, glass shards, or paraformaldehyde residues, those particles do not dissolve. Instead, they remain as discrete foreign bodies. As the IV drip flows into the vein, these particles are carried along with the blood flow. The smallest of these can travel all the way to the capillaries in vital organs such as the lungs, brain, kidneys, and eyes. Once a particle is too large to pass through the narrowest blood vessels, it can become lodged, causing a blockage known as an embolism. Even microscopic glass or hardened chemical residues can trigger an inflammatory response, damaging the delicate lining of blood vessels (endothelium) and potentially leading to tissue injury or immune reactions.
It is important to distinguish between different types of particulates because they pose different risks. Glass particles are rigid and sharp; if they lodge in a vessel, they can cause mechanical damage or micro-tears. Hair is organic matter that introduces a significant risk of infection or severe inflammatory reaction, as the body recognizes it as a foreign invader. Paraformaldehyde, a polymer of formaldehyde, is particularly concerning because it is a chemical irritant and potential toxin. If introduced directly into the bloodstream, it can cause local irritation, toxicity, or allergic-type reactions at the site of injection or in distant organs where it settles. The combination of these materials suggests a serious failure in the manufacturing or packaging environment, where cleanliness standards were not maintained.
This type of contamination is especially hazardous because IV medications are typically administered to patients who are already vulnerable—those undergoing surgery, trauma care, or treatment for bleeding disorders. These patients may have compromised immune systems or fragile blood vessels, making them less able to tolerate the additional stress that foreign particles impose on their circulatory system. The risk is not just immediate; embedded particles can remain in tissues long after the infusion is complete, potentially causing chronic inflammation or other delayed complications. Therefore, the presence of any visible particulate matter in an IV drug is considered a critical safety failure, warranting an immediate Class II recall to prevent serious health consequences.
Who is most at risk
To understand who is truly vulnerable in this situation, we first need to look at what AMINOCAPROIC ACID actually does and who typically needs it. This medication is a prescription drug known as an antifibrinolytic agent. In simple terms, it helps your blood clot properly by stopping the body from breaking down clots too quickly. Because of this specific function, it is not a medication you would find in a home medicine cabinet for minor ailments. Instead, it is almost exclusively used in controlled medical settings—such as hospitals, surgical centers, or specialized clinics—and is administered directly into the bloodstream via an intravenous (IV) line. This means the primary group of people at risk here are patients who are currently undergoing surgery, particularly those involving the heart, lungs, or prostate, or individuals with bleeding disorders like hemophilia. It is also sometimes used to treat severe bleeding after trauma or in cases of excessive fibrinolysis, where the blood’s natural clotting mechanism goes into overdrive.
The specific hazard in this recall involves particulate matter—tiny foreign objects such as hair, glass fragments, and paraformaldehyde—present inside the vials. For a healthy person receiving an oral pill, a contaminant might be harmless or easily filtered by the body. But for patients receiving an IV infusion, the risk profile changes dramatically. When these particles are injected directly into the vein, they bypass the body’s natural filtration systems in the lungs and liver. If these particulates are large enough, they can physically block small blood vessels, a condition known as embolism. This can lead to serious complications depending on where the blockage occurs. For example, particles traveling to the lungs can cause pulmonary emboli, leading to shortness of breath or lung damage. Particles reaching the brain could theoretically contribute to stroke-like symptoms, while those affecting the heart can disrupt blood flow to cardiac tissue.
Certain patient groups are particularly vulnerable to these complications. Elderly patients often have more fragile blood vessels and may already have compromised circulation, making them less able to tolerate even minor blockages. Patients with pre-existing lung conditions, such as COPD or pulmonary hypertension, are at higher risk because their lungs are already working harder; adding a physical obstruction can severely reduce oxygen exchange. Additionally, individuals with weakened immune systems, often seen in cancer patients or those on immunosuppressant therapy, may face greater risks if the particulate matter introduces any biological contaminants, although the primary concern here is physical blockage. Children, while less likely to be prescribed this specific high-dose IV medication for routine care, are also highly sensitive to vascular obstructions because their blood vessels are smaller in diameter, meaning a particle that might pass harmlessly through an adult’s larger vein could cause a significant blockage in a child.
It is also important to note who might be at risk indirectly. Healthcare providers administering the drug are not physically harmed by the particulates in the same way patients are, but they bear the responsibility of identifying and stopping the use of this product immediately. Pharmacists and nurses who prepare the IV bags must be vigilant because these particles can sometimes be difficult to see with the naked eye, especially if they are microscopic or transparent like glass. Therefore, while the patient is the direct victim of the hazard, the entire care team is part of the risk management chain. If you or a loved one is scheduled for surgery or treatment involving this drug, knowing these details allows you to ask your medical team about their quality control checks and whether they have verified the lot numbers of the medications they are using.
How to tell if you have the recalled item
Identifying whether you possess the specific batch of medication involved in this FDA recall requires careful attention to several distinct details on the packaging. Because American Regent, Inc. manufactures AMINAOCAPROIC ACID INJECTION, USP, for intravenous use, the product will not look like a standard over-the-counter pill bottle. Instead, you are looking for clear glass vials designed for clinical or hospital settings. To confirm if your item is part of this recall, you must verify four specific pieces of information: the brand name, the National Drug Code (NDC), the lot number, and the expiration date. If even one of these details does not match the records exactly, your product is not affected by this Class II recall.
First, check the label for the brand name. The recalled products are manufactured by American Regent, Inc., located in Shirley, New York. You should see the drug name clearly printed as AMINAOCAPROIC ACID INJECTION, USP. It is crucial to note the concentration and volume, which must be 250 mg/mL, with each vial containing 5 grams of the active ingredient in a 20 mL size. The packaging comes in two specific configurations for this recall: either a single 20 mL multiple-dose vial intended for IV infusion, or a carton containing 25 of these 20 mL multiple-dose vials. If your vials are a different volume, concentration, or from a different manufacturer, they are not part of this specific safety alert.
The most critical identifiers for verification are the National Drug Code (NDC) and the lot number. You need to locate the NDC on the label, which serves as a unique identifier for the drug’s labeler, product, and trade package size. For this recall, there are exactly two NDCs associated with the affected products. The first is NDC 0517-9120-01, which corresponds to the single 20 mL multiple-dose vial. The second is NDC 0517-9120-25, which corresponds to the package containing 25 of the 20 mL multiple-dose vials. If your packaging does not display one of these two specific codes, it is safe from this particular recall.
Next, look for the lot number and the expiration date printed directly on the vial or its carton. The recall applies strictly to Lot # 24299. This number is typically found near the NDC or in a designated box on the label. Finally, check the expiration date. The affected lots expire on August 31, 2026. If your lot number is anything other than 24299, or if the expiration date is different, your product is not included in this recall action. Please do not rely on visual inspection of the liquid itself, as the presence of particulate matter such as hair, glass, or paraformaldehyde may not be visible to the naked eye. Only the printed identifiers can confirm whether your item is subject to this safety notice.
- Brand: American Regent, Inc.
- Product Name: AMINAOCAPROIC ACID INJECTION, USP, 250 mg/mL (5 g/20 mL)
- Packaging Types: Single 20 mL multiple-dose vial OR Carton of 25x20 mL multiple-dose vials
- NDC Codes: 0517-9120-01 or 0517-9120-25
- Lot Number: 24299
- Expiration Date: 8/31/2026
What to do — step by step
If you are a healthcare provider, pharmacist, or hospital inventory manager currently in possession of the recalled AMINAOCAPROIC ACID INJECTION, USP, 250 mg/mL (5 g/20 mL), produced by American Regent, Inc., immediate action is required to protect patient safety. Because this recall involves Class II hazards where exposure to particulate matter such as hair, glass, or paraformaldehyde can lead to serious adverse health consequences, you must not administer these products under any circumstances. The primary and most critical step is to immediately quarantine the affected stock. This means physically separating the vials from your active inventory to prevent accidental use. Do not simply move them to a different shelf; place them in a clearly marked, restricted area that is inaccessible to clinical staff who may be looking for medication during an emergency.
Next, you must verify exactly which units are impacted by checking the lot number and expiration date against the recall details. The specific lots included in this FDA recall are Lot #24299 with an expiration date of 8/31/2026. This applies to two specific packaging configurations: the single 20 mL multiple dose vial for IV infusion (NDC 0517-9120-01) and the case containing 25x20 mL multiple dose vials (NDC 0517-9120-25). If your inventory records show any quantity of these National Drug Codes associated with Lot #24299, those units are part of the recall. It is essential to document this finding thoroughly for your internal compliance records and for any future correspondence with the manufacturer.
Regarding the remediation process, the official FDA recall facts do not currently state a specific remedy, such as a prepaid return shipping label, a direct refund process, or instructions for repair. Because this specific guidance is absent from the current public notice, you should contact American Regent, Inc., directly at their facility in Shirley, NY 11967, to inquire about their specific disposal protocols or replacement procedures. Do not attempt to dispose of the contaminated vials in regular medical waste streams without confirmation from the manufacturer, as particulate contamination may require special handling instructions to ensure safety during disposal. If you have already administered a dose from this lot and suspect exposure, seek immediate medical attention for the patient and report the adverse event to the FDA MedWatch program.
Finally, communicate this recall to all relevant staff members promptly. Ensure that nurses, pharmacists, and procurement officers are aware that Lot #24299 is out of service. Replace the quarantined product with a lot from a different manufacturer or a different production run from American Regent that has not been recalled, ensuring that your supply chain continuity is maintained without compromising safety standards. Vigilance in this step helps prevent any potential legal or clinical complications arising from the use of contaminated injectable solutions.
Your refund, repair, or replacement options
When a product recall occurs, the most immediate concern for patients, caregivers, and healthcare providers is often: "What happens next?" In this specific instance involving American Regent, Inc.’s AMINAOCAPROIC ACID INJECTION, USP, the official recall documents do not explicitly list a standardized remedy such as a direct mail-in refund, a prepaid shipping label for returns, or an automatic replacement program. This absence of stated terms in the public record is not unusual for Class II drug recalls initiated by the FDA, particularly when the timeline is recent (July 24, 2026) or when the distribution was primarily through professional healthcare channels rather than retail pharmacies. Therefore, while we cannot provide you with a pre-written return address or a specific customer service phone number from this text, understanding how these processes typically work can help you navigate the situation with confidence and clarity.
First, it is important to recognize that for prescription injectable drugs like AMINAOCAPROIC ACID, "repair" is not a viable option. You cannot fix particulate contamination. The only safe course of action is to cease use immediately and isolate the product. If you are a patient who has already purchased or been prescribed this medication but have not yet used it, your primary point of contact should be the pharmacy where you filled the prescription or the hospital outpatient department that administered it. These entities hold the direct contractual relationship with American Regent, Inc., located in Shirley, NY. They are responsible for initiating the return process on your behalf. Typically, healthcare facilities will receive specific instructions from the manufacturer or the FDA detailing how to dispose of the recalled lots (Lot #24299) and how to process credits or replacements for affected patients.
If you are a member of the public who may have acquired this product through non-standard channels—which is less common for Rx-only IV infusions—you should contact American Regent, Inc. directly. Although the specific contact details (phone number or email) are not included in the provided recall facts, you can locate them via the FDA’s official recall database or by visiting the American Regent website. When you reach out, have your NDC numbers (0517-9120-01 or 0517-9120-25) and the lot number ready. This ensures they can quickly verify that your specific vials are part of the affected batch. Be prepared to provide proof of purchase if you are seeking a refund, as this helps confirm your eligibility for reimbursement under any unpublicized customer care policies.
For healthcare professionals holding inventory, do not attempt to return these vials through standard waste disposal streams due to the nature of the contamination (particulate matter including glass and hair). Follow the specific hazardous material protocols provided by American Regent upon contact. If you have administered this drug to a patient prior to the recall notice, monitor for any adverse reactions and report them to the FDA MedWatch program. While the recall itself addresses the product safety, reporting clinical outcomes helps authorities understand the full scope of the hazard. Remember, your health is the priority; if you are unsure whether your specific vial is affected, err on the side of caution and consult your healthcare provider before making any decisions about usage or return.
What can happen if you ignore it
When a medication is recalled due to the presence of foreign particulate matter—such as hair, glass shards, or chemical residues like paraformaldehyde—the decision to continue using that product is not merely a matter of inconvenience; it is a direct threat to physiological safety. Aminocaproic acid injection is designed for intravenous (IV) use, meaning it enters the bloodstream directly, bypassing the body’s natural filtration systems like the stomach or skin. Because of this delivery method, any contaminant present in the vial has a clear and immediate pathway to reach vital organs, including the heart, lungs, and kidneys.
If you continue to administer this recalled product, the most immediate risk is physical trauma to the blood vessels and tissues. Glass particulates, even when microscopic, are rigid and sharp. As the fluid is pushed through an IV line and into a vein, these shards can cause micro-abrasions to the vessel lining. This can lead to inflammation, local tissue damage, or the formation of small clots (emboli). If these particles travel further into circulation, they may lodge in narrow capillaries, particularly in the lungs (pulmonary embolism) or brain, potentially causing blockages that impair oxygen flow or nerve function. Hair and other organic debris can also introduce biological contaminants, raising the risk of infection or severe allergic reactions at the injection site or systemically.
Beyond physical trauma, the presence of paraformaldehyde introduces a significant chemical hazard. Paraformaldehyde is a polymer that can release formaldehyde gas or monomers under certain conditions. Formaldehyde is known to be toxic and irritating to tissues. If introduced directly into the bloodstream, it can cause cellular damage, trigger severe inflammatory responses, or lead to systemic toxicity. The body’s immune system may react aggressively to these foreign chemical agents, resulting in fever, chills, nausea, or more serious organ stress as the liver and kidneys work to filter out the toxins.
It is important to note that while the FDA recall announcement does not currently report specific injuries or fatalities linked to this particular lot, the absence of reported harm does not mean the risk is low. Many adverse events go unreported until they become severe. By ignoring a Class II recall, you are essentially gambling with your vascular integrity and chemical balance. The consequences of ignoring this warning could range from acute pain and infection at the injection site to life-threatening complications such as sepsis, organ failure, or stroke. In medical contexts, prevention is always far less dangerous than treatment. Continuing to use a contaminated IV solution turns a manageable pharmaceutical error into a potential emergency room scenario.
Staying safe: broader tips
When it comes to medications administered intravenously, particularly those used in critical care or surgical settings, the integrity of the sterile environment is just as important as the chemical composition of the drug itself. While recalls like this one highlight specific manufacturing lapses, your best defense is a combination of rigorous visual inspection and strict adherence to handling protocols. Always take a moment to hold any vial up to the light before use. You are looking for clarity; if the liquid appears cloudy, discolored, or contains any visible specks, fibers, or shards, do not administer it. This simple act of verification can prevent particulate matter from entering your bloodstream, which is especially crucial because intravenous particles can cause blockages in small blood vessels or trigger inflammatory responses.
Beyond the moment of administration, proper storage plays a vital role in maintaining medication safety. Ensure that all injectable drugs are stored according to the manufacturer’s temperature and humidity guidelines. Improper storage can sometimes degrade packaging materials or promote microbial growth, which compromises the sterility you rely on when a needle pierces the vial stopper. If you are managing medications at home under a doctor’s supervision, keep them in their original containers until the last possible moment to protect them from light and environmental contaminants.
It is also wise to establish a routine of checking for safety alerts regularly. Many people wait until they have a problem before looking into product recalls, but proactive monitoring can save you from exposure entirely. Sign up for email notifications from the FDA’s Office of Consumer Affairs or download official government safety apps that push alerts directly to your device. By staying informed about which manufacturers and lot numbers are currently under review, you can contact your healthcare provider or pharmacist immediately if you have a product in question, rather than waiting for symptoms to appear.
Finally, always communicate openly with your healthcare team. If you notice anything unusual about the packaging, such as torn seals, incorrect labeling, or discrepancies in the expiration date, report it right away. Your provider can help verify whether the item is part of a recall and guide you on next steps. Remember that safety is a shared responsibility; by staying vigilant and informed, you help ensure that your treatment remains effective and free from avoidable hazards.