What was recalled
The U.S. Food and Drug Administration (FDA) has issued a voluntary recall for a specific pharmaceutical product manufactured by Chiesi USA, Inc., headquartered in Cary, North Carolina. This action involves the drug Revcovi (elapegademase-lvlr), which is supplied as an injection intended for intramuscular use only. The medication is available solely by prescription and comes in single-dose vials with a concentration of 2.4mg per 1.5mL, equating to a strength of 1.6 mg/mL. It is critical to identify the precise product details because recalls often target specific batches rather than the entire brand line, ensuring that only affected units are removed from circulation while safe stock remains available for patients who depend on the therapy.
The specific item caught in this recall carries the National Drug Code (NDC) 10122-502-01. This unique identifier is your primary tool for verification. If you have a prescription bottle or vial, look closely at the label for this exact code. The recall applies specifically to Lot number 1221973. While the expiration date for this lot is listed as March 24, 2027, meaning the product was not yet past its prime when the recall occurred, it fails to meet internal quality standards regarding its stability. The FDA classifies this as a Class III recall, which typically denotes a situation where the use of the product is unlikely to cause adverse health consequences but still violates federal labeling or manufacturing laws.
Regarding the scope of distribution, the records indicate that these affected vials were distributed in the states of Missouri and Tennessee. The official date of this recall action is recorded as August 19, 2026. It is important to note that while the manufacturer is located in North Carolina, the physical product did not necessarily stay there; it moved through supply chains into the two aforementioned states. If you reside in or recently traveled through Missouri or Tennessee and have been prescribed Revcovi, this is a crucial piece of context for your next steps.
Unfortunately, the official FDA recall notice does not state the exact number of units affected by this specific lot. In cases where the quantity is not explicitly listed in the public summary, it suggests that the volume may be limited or that the data is still being aggregated by the manufacturer and regulatory bodies. However, the specificity of the lot number (1221973) allows for precise tracking. If you do not have your vial handy, contact your pharmacy immediately with the lot number and NDC to verify if your specific supply is included in this batch.
- Product Name: Revcovi (elapegademase-lvlr) Injection
- Manufacturer: Chiesi USA, Inc.
- NDC: 10122-502-01
- Lot Number: 1221973
- Expiration Date: 3/24/2027
- Recall Date: 2026-08-19
- Distribution States: Missouri, Tennessee
The hazard, explained
At the core of this recall is a subtle but critical issue with the physical stability of the medication itself. The U.S. Food and Drug Administration (FDA) identified that specific lots of Revcovi failed to meet established stability specifications regarding its protein concentration profile. To understand why this matters, it helps to look at what Revcovi actually is. It is not a simple chemical pill; it is a complex biological product known as an enzyme replacement therapy. The active ingredient, elapegademase-lvlr, is a protein engineered to function as a substitute for an enzyme called purine nucleoside phosphorylase (PNP) that the body needs to process certain molecules in the blood.
Proteins are delicate structures. Their effectiveness depends entirely on them folding into a precise three-dimensional shape, much like a key must fit perfectly into a lock to work. When the FDA notes a failure in the "protein concentration profile," it indicates that the protein within these specific vials may have degraded, clumped together, or changed its structural integrity during storage or transport. This degradation can happen due to various environmental factors, such as temperature fluctuations, even if the product was handled correctly according to standard guidelines. The result is a medication that is no longer chemically consistent with what was tested and approved for safety.
Why does this lead to harm? The primary risk of using a degraded enzyme replacement therapy is twofold: it may not work when you need it to, or it could trigger an unintended immune response. If the protein structure has altered, the enzyme may lose its ability to break down toxic metabolites (specifically deoxyguanosine) that build up in patients with PNP deficiency. For these patients, allowing those toxins to accumulate can lead to severe immune system dysfunction and other serious health complications. Essentially, the treatment fails to perform its life-sustaining function.
Furthermore, there is a secondary risk associated with altered protein structures: immunogenicity. When proteins degrade or change shape, the body’s immune system may recognize them as foreign invaders rather than helpful tools. This can lead to the production of antibodies against the medication itself. In some cases, this results in an allergic reaction or infusion-related side effects that are more severe than those typically seen with stable, properly manufactured doses. While this specific recall does not report any current incidents of injury, the potential for reduced efficacy and increased adverse reactions is significant enough to warrant a Class III classification, indicating a situation where use could lead to minor health consequences or where the product fails to meet critical quality standards.
It is important to note that stability failures are often unpredictable and can occur even in products that appear normal. You cannot tell if a vial has failed its stability specifications by looking at it, smelling it, or checking the expiration date on the box. The degradation happens at a molecular level long before any visible changes like cloudiness or particles might appear. Therefore, the only way to ensure you are receiving a safe and effective dose is to verify the lot number against the official recall list, as visual inspection alone is not a reliable safety check for biological products.
Who is most at risk
When we talk about who is "at risk" in this specific recall, it is important to distinguish between two very different types of vulnerability. First, there are the individuals who physically possess the recalled medication and rely on it for their daily treatment. Second, there are the patients whose medical outcomes might be compromised because the drug they are using does not meet the strict stability specifications required for its intended purpose. Understanding this distinction helps clarify why this Class III recall matters, even though the FDA has not linked it to any reported injuries or adverse events yet.
The primary group affected by this recall consists of patients who have been prescribed Revcovi (elapegademase-lvlr). This is a prescription-only medication used to treat Heparin-induced thrombocytopenia, a condition where the blood does not clot properly after exposure to heparin. Because Revcovi is a specialized enzyme replacement therapy, its users are typically individuals who require precise, consistent dosing to manage their health effectively. If you or someone in your household has been prescribed this drug by a healthcare provider, you are part of the group that needs to take immediate action to verify whether your specific vial is included in this recall.
The people most vulnerable to the potential consequences of this recall are those who depend on the protein concentration profile of Revcovi to function correctly. The hazard here is a "failed stability specification," specifically regarding the protein concentration. In plain terms, this means that testing showed the amount of active drug in the vial may not be what the label claims. For patients with serious underlying health conditions, receiving a dose that is either too weak or potentially unstable can disrupt their treatment plan. While the recall does not suggest the drug is toxic or harmful in a dangerous way, it does raise concerns about whether the patient is getting the full therapeutic benefit they need.
Additionally, while the general public is not at risk, patients in Missouri (MO) and Tennessee (TN) who received distributed lots from this batch should be particularly vigilant. Although the distribution pattern is limited, the vulnerability lies in the fact that these patients may have already administered the dose or are storing it for future use. Since the product is for intramuscular use only and comes in single-dose vials, there is no opportunity to return the drug to a shelf; once it leaves the facility, it is in the hands of the patient or their caregiver. Therefore, the responsibility falls on these specific patients to contact their pharmacy or healthcare provider immediately to confirm if their lot number, 1221973, is part of this recall. Ignoring this could mean continuing a treatment regimen that might not be performing as expected, which can have subtle but significant impacts on long-term health management.
How to tell if you have the recalled item
If you or a loved one are currently being treated with Revcovi (elapegademase-lvlr), verifying whether your specific supply is part of this recall is a straightforward process that relies on checking two critical pieces of information: the National Drug Code (NDC) and the lot number. Because this recall involves a prescription-only injectable medication, you likely did not purchase it at a standard retail store with a price tag in hand. Instead, your first step should be to locate the physical vial or the packaging materials that arrived with your most recent shipment from Chiesi USA, Inc., or consult the detailed dispensing records provided by your pharmacy or healthcare provider.
Begin by examining the label on the single-dose vial itself. You need to look for a specific combination of identifiers that confirm you have the exact product affected by this stability issue. First, ensure the drug name matches Revcovi (elapegademase-lvlr). Next, verify the strength and volume, which must be listed as 2.4mg/1.5mL, corresponding to a concentration of 1.6 mg/mL. The packaging should also clearly state that this is an injection for intramuscular use only and contains a single dose.
The most crucial step, however, is matching the unique lot number. According to FDA records, this recall applies exclusively to the following details:
- NDC Number: 10122-502-01
- Lot Number: 1221973
- Expiration Date: March 24, 2027 (Exp 3/24/2027)
If the lot number on your vial is anything other than 1221973, or if the NDC differs from 10122-502-01, your product is not part of this specific recall. It is important to note that while the expiration date is listed as March 2027, the recall was issued on August 19, 2026, due to failed stability specifications regarding the protein concentration profile, rather than a general expiration issue. This means the drug may look and function normally but does not meet safety standards.
If you are unable to locate the physical vial or if your records are unclear, contact the pharmacy that filled your prescription immediately. They maintain detailed logs of NDCs and lot numbers for every dispensed item. If you are a healthcare provider managing distribution in the affected states of Missouri (MO) and Tennessee (TN), check your inventory logs against the manufacturer's data from Chiesi USA, Inc., located in Cary, NC. Do not rely on visual inspection alone; the label information is the only definitive way to confirm if your supply is implicated in this Class III recall.
What to do — step by step
If you are a patient, caregiver, or healthcare provider involved with the Chiesi USA, Inc. recall of Revcovi (elapegademase-lvlr) Injection, it is natural to feel a mix of confusion and concern. The first thing to understand is that this specific recall, announced by the FDA on August 19, 2026, is classified as a Class III action. In regulatory terms, this means the violation is not immediately life-threatening in the same way a contamination might be, but it is still serious because the product did not meet its own strict stability specifications. Specifically, the protein concentration profile was found to be out of specification. While this does not mean the drug is "poisonous," it does mean that the potency or efficacy of the medication may not be what is listed on the label. Therefore, taking action is necessary to ensure you do not unknowingly receive a product that might not work as intended for your treatment plan.
The most critical step you must take immediately is to stop using any vials that match the recalled details. You should physically separate these items from your other medications and clearly label them as "DO NOT USE" to prevent accidental administration. The affected product is Revcovi Injection, 2.4mg/1.5mL (1.6 mg/mL), in single-dose vials intended for intramuscular use only. It is manufactured by Chiesi USA, Inc., located in Cary, North Carolina. To verify if you have the recalled item, you must check two specific identifiers: the National Drug Code (NDC) and the Lot Number. The recalled NDC is 10122-502-01, and the specific lot number involved is 1221973. Please note that this recall applies only to lots with an expiration date of March 24, 2027. If your vial has a different lot number or expiration date, it is likely not part of this specific recall, but you should always double-check with your pharmacist or the manufacturer to be absolutely certain.
Because the official FDA recall notice does not currently state a specific remedy—such as a direct mail-in return address, a prepaid shipping label, or an automatic refund process—you must take proactive steps to contact the responsible parties. Your first point of contact should be the healthcare professional who prescribed or administered the Revcovi. They need to know immediately so they can document the issue in your medical record and advise you on whether you need a replacement dose or if you can wait for updated instructions. Next, you should contact Chiesi USA, Inc., directly. They are the manufacturer and will have the most accurate information regarding how they intend to handle this distribution pattern, which currently includes Missouri, Tennessee, and North Carolina.
When you reach out to Chiesi or your healthcare provider, have all the physical details of the vial ready. This includes the NDC 10122-502-01, Lot 1221973, and the expiration date of 3/24/2027. Ask them explicitly: "What is the current instruction for this lot?" Since the remedy is not stated in the initial alert, they may provide instructions to return the product to their facility for analysis, or they may authorize you to keep it until further notice if the risk is deemed low by their internal quality team. Do not dispose of the vial in your household trash until you have received specific disposal instructions from a medical professional or the manufacturer, as improper disposal could pose safety risks to others.
If you are a pharmacy or healthcare facility that has dispensed this product, you must quarantine all remaining inventory associated with Lot 1221973 immediately. Do not attempt to repackage or redistribute these vials. Document which patients received doses from this lot so that your care team can monitor them for any potential issues related to inconsistent protein concentration. While the hazard here is a failure in stability specifications rather than microbial contamination, ensuring the integrity of your supply chain is vital for patient trust and safety. Stay calm, but stay vigilant. Keep records of all communications with Chiesi USA, Inc., and your healthcare providers. This documentation will be helpful if any questions arise later regarding your treatment continuity or potential refunds.
Your refund, repair, or replacement options
When you encounter a product recall, the most immediate question often revolves around what happens next financially and practically. In this specific case involving Chiesi USA, Inc.’s recall of Revcovi (elapegademase-lvlr) Injection, it is important to approach the situation with clarity and patience. The official recall documentation provided by the U.S. Food and Drug Administration (FDA) does not explicitly state a specific remedy such as a direct refund, a repair service, or an automatic replacement shipment in the available text. While this might feel like an incomplete answer, it is actually quite common for pharmaceutical recalls, particularly those classified as Class III and related to stability specifications, to handle restitution through different channels than consumer electronics or household goods.
Because the recall was issued due to "failed stability specifications"—specifically an out-of-specification result for the protein concentration profile—the primary concern is safety and efficacy rather than a manufacturing defect that renders the device unusable in a traditional sense. For a drug like Revcovi, which is prescribed for intramuscular use only, "repair" is not a logical option. You cannot fix the chemical stability of a single-dose vial once it has left the controlled environment of the manufacturer. Therefore, the standard industry remedy for this type of recall typically involves the return of the product to the manufacturer or its authorized distributor for proper disposal and credit issuance.
Even though the specific contact details and financial terms are not listed in the immediate summary, the process generally follows a strict protocol for Rx-only medications. As a patient or healthcare provider, you should not attempt to dispose of this medication yourself. Instead, your first step must be to contact the prescribing physician or the pharmacy where the prescription was filled. They serve as the critical link to Chiesi USA, Inc. In Cary, NC, where the product was manufactured, there is a dedicated recall team responsible for managing these logistics. They will likely provide you with a prepaid shipping label and specific instructions on how to return Lot# 1221973 (Exp 3/24/2027) if it has been dispensed but not yet used.
If the product was already administered, the focus shifts from financial restitution to medical monitoring. However, for any unused vials in your possession or in a clinic’s stock in Missouri, Tennessee, or North Carolina, do not use them. The lack of stated refund terms in the brief does not mean you are left without recourse; it simply means the administrative process is handled directly between healthcare providers and the manufacturer. Chiesi USA, Inc. is legally obligated to facilitate the removal of these products from the market. You should ask your pharmacist or doctor to confirm whether a credit for the cost of the drug will be issued once the recall is processed. This ensures that you are not financially penalized for a safety issue that was entirely outside your control.
In summary, while the "remedy" section of the recall notice is quiet on specific dollar amounts or replacement timelines, the path forward is clear: do not use the product, secure it safely away from patients, and rely on your healthcare provider to initiate the return process with Chiesi USA, Inc. They will handle the complexities of the distribution pattern across MO, TN, and NC to ensure that every affected vial is accounted for and replaced or credited appropriately.
What can happen if you ignore it
When a pharmaceutical product is recalled due to stability issues, the immediate concern isn’t always a sudden, visible change in the liquid itself. In the case of Revcovi (elapegademase-lvlr), the specific hazard involves failed stability specifications related to the protein concentration profile. This means that the actual amount of active drug ingredient in the vial may not match what is printed on the label. While this might sound like a minor discrepancy, for a medication used to treat a serious genetic condition, consistency is everything. Ignoring this recall and continuing to use the affected lots carries significant risks that extend far beyond simple inconvenience.
The primary danger lies in unpredictable therapeutic outcomes. Elapegademase-lvlr is an enzyme replacement therapy designed to break down specific toxins in the body. If the protein concentration is lower than intended due to degradation or instability, you may receive a sub-therapeutic dose. This means the medication might not effectively manage your condition, potentially allowing harmful metabolites to build up in your system. Conversely, if the instability has led to unpredictable aggregation or other chemical changes, the efficacy could be compromised in ways that are not easily measured by looking at the vial. You cannot tell by sight, smell, or taste whether the protein structure has remained stable. The liquid may look perfectly clear and normal, masking the fact that its biological activity is unreliable.
For patients with HGD (hereditary galactosemia), maintaining strict control over enzyme levels is critical to preventing long-term complications. Inconsistent dosing can lead to fluctuations in your metabolic state. This instability can result in a return of symptoms that were previously under control, such as gastrointestinal distress, bone pain, or other systemic issues associated with the buildup of galactitol. Over time, relying on a product that does not deliver its promised potency can lead to a gradual decline in health management, forcing your healthcare provider to adjust treatments more frequently and potentially with higher doses to compensate for the lost efficacy.
There is also the risk of adverse reactions related to protein instability. When proteins degrade or aggregate unexpectedly, they can sometimes trigger immune responses that are different from those caused by the stable drug. While the recall facts do not report specific injuries yet, the potential for increased immunogenicity—where your body attacks the altered protein as a foreign invader—is a known risk in biologic therapies. This could manifest as infusion-related reactions, allergic responses, or other inflammatory symptoms that are difficult to distinguish from your underlying condition without careful medical monitoring.
Ultimately, ignoring the recall means gambling with your health based on a label you can no longer trust. The manufacturer has identified a flaw in the product’s shelf-life stability, and continuing to use these vials removes the safety net provided by regulatory standards. You are essentially administering an unverified dose of medication. This uncertainty can cause significant anxiety and disrupt your treatment plan. The safest path is to stop using the affected lots immediately and contact your healthcare provider to discuss a replacement strategy that ensures you receive a product with guaranteed potency and stability.