What was recalled
The Food and Drug Administration (FDA) has issued a Class II recall for Acthar Gel, which is the trade name for repository corticotropin injection. This medication is manufactured by Mallinckrodt Hospital Products Inc., with distribution handled by Mallinckrodt ARD LLC, located in Bridgewater, New Jersey. The specific items involved in this recall are 5 mL multiple-dose vials of Acthar Gel marked as prescription-only (Rx Only). These vials are not single-use; they are designed to allow for multiple injections over time, which makes the integrity of the container and its seal critically important for patient safety.
The scope of this recall is nationwide, affecting patients across all 50 states who may have received these specific batches from pharmacies or healthcare providers. The affected products are identified by their National Drug Codes (NDC) and lot numbers, which serve as the unique fingerprints for each batch produced. Specifically, the recall covers NDC 63004-8710-1 with Lot Number 1564-107, and NDC 63004-8710-2 with Lot Number 1564-107H. Both of these lots share an expiration date of January 31, 2027. It is important to note that while the expiration date is in the future, the presence of foreign materials within the vials renders them unsafe for use regardless of their shelf life.
This recall was initiated on August 6, 2026. The classification as a Class II recall by the FDA indicates that the failure of the product to meet safety standards is not likely to cause serious adverse health consequences or death, but it could result in temporary or medically reversible health problems. However, this does not diminish the importance of removing these specific vials from circulation. The presence of particulate matter—specifically glass fragments and pieces of the rubber stopper—inside a medication intended for injection poses a significant risk of embolism, tissue damage, or infection at the injection site.
If you have recently received Acthar Gel, it is crucial to verify your vial against the specific NDCs and lot numbers listed above. The recall applies strictly to these identified batches manufactured by Mallinckrodt ARD LLC. Other lots or different concentrations of Acthar Gel are not included in this specific action unless separately announced. Healthcare providers and patients should check their inventory immediately to ensure that no vials from Lot 1564-107 (associated with either NDC 63004-8710-1 or 63004-8710-2) are being used or stored for future use.
The hazard, explained
When you look at a vial of Acthar Gel, you are seeing a medication designed to be injected directly into your body’s tissues or bloodstream. The specific danger in this recall stems from the physical integrity of the container itself. During the manufacturing process for certain lots of this repository corticotropin injection, foreign objects—specifically fragments of glass and pieces of the rubber stopper that seals the top of the vial—found their way into the product. This is not a chemical contamination issue where a toxin was introduced; rather, it is a mechanical failure where solid debris became trapped inside the sterile fluid.
To understand why this is dangerous, it helps to look at how these multiple-dose vials are designed to work. Each time a healthcare provider needs to draw medication from the vial, they must push a needle through the rubber stopper. The presence of loose glass shards or rubber pieces means that the internal environment of the vial has been compromised by manufacturing defects. These particles do not dissolve. They remain suspended in the gel-like substance, waiting to be drawn up into a syringe along with the medicine.
The primary risk occurs at the moment of injection. If these particulate matters are injected subcutaneously (under the skin) or intramuscularly (into the muscle), they act as foreign bodies that your body cannot absorb or break down. The human immune system is designed to react to invaders. When it encounters glass shards or rubber fragments, it may trigger a localized inflammatory response. This can lead to pain, swelling, redness, and granuloma formation—a type of hard lump where the body walls off the foreign material. In sensitive areas, this can cause significant discomfort and tissue damage that requires medical intervention to resolve.
In more severe scenarios, particularly if the medication is intended for intravenous use or if the particles are sharp enough, there is a risk of vascular obstruction or embolism. Even small fragments can block tiny blood vessels, preventing proper blood flow to downstream tissues. While this is less common with subcutaneous injections, the potential for internal injury remains a serious concern because these particles are invisible to the naked eye in many cases. You might not see the debris until you hold the vial up to the light and inspect it carefully against a dark background, which is why visual inspection is critical before every use.
Furthermore, the presence of stopper pieces suggests that the sealing mechanism of the vial may have been compromised during assembly. If the rubber stopper was not properly seated or if fragments broke off during the capping process, it raises questions about the sterility of the product. While the recall notice specifically cites particulate matter as the hazard, any breach in the container’s integrity increases the theoretical risk of microbial contamination, even if bacteria are not currently present. For patients relying on this medication for conditions involving inflammation or immune system regulation, introducing unexpected physical trauma to the injection site can complicate treatment outcomes and delay healing.
Who is most at risk
To understand who is most vulnerable in this specific recall, we first need to look at what Acthar Gel actually is and why it is prescribed. This medication contains repository corticotropin injection, which is a form of adrenocorticotropic hormone (ACTH). It is not a common over-the-counter remedy found in every medicine cabinet; it is a prescription-only drug used to treat a variety of complex autoimmune and inflammatory conditions. Because of its specialized nature, the people at risk are primarily those living with chronic health issues that require immune system modulation. This includes patients with multiple sclerosis, rheumatoid arthritis, dermatomyositis, systemic lupus erythematosus, and other serious connective tissue disorders. It is also sometimes used in diagnostic procedures to help identify certain adrenal gland problems. Therefore, the group most at risk is not the general public walking down the street, but rather a specific, medically fragile population who rely on this drug for disease management.
The primary hazard identified in this recall is the presence of particulate matter—specifically glass fragments and pieces of rubber stopper—inside the 5 mL multiple-dose vials. This poses a unique and severe risk to anyone who has been prescribed these specific lots (1564-107 and 1564-107H) with expiration dates of January 31, 2027. The danger here is twofold: physical injury and contamination. When a patient or healthcare provider draws medication from a multiple-dose vial, they insert a needle through the rubber stopper. If that stopper is defective and shedding pieces, those rubber fragments can enter the syringe along with the liquid medication. Similarly, if glass shards are present in the vial, they may be drawn into the needle. Injecting these foreign objects directly into the body bypasses the natural filtration systems of the skin and digestive tract.
While any adult receiving this injection is at risk of serious complications such as embolisms, tissue damage, or infection, certain groups within this patient population may face heightened vulnerability. Elderly patients, who often manage multiple chronic conditions simultaneously, may have more fragile blood vessels or compromised immune systems, making them less able to withstand the inflammatory response triggered by particulate injection. Additionally, patients with autoimmune diseases are already dealing with an overactive or misdirected immune system; introducing foreign material like glass or rubber into their bloodstream could trigger unpredictable and severe local reactions at the injection site or systemic inflammatory responses that complicate their primary treatment. Because Acthar Gel is often used for long-term management of chronic conditions, patients may be receiving repeated doses from the same batch over time, increasing the cumulative exposure risk if the defect persists across multiple vials.
It is also important to note that healthcare providers administering these injections in clinical settings share this risk. Nurses, doctors, and pharmacists who handle these specific Mallinckrodt Hospital Products Inc. vials are exposed to the same particulate hazard during the preparation process. A breakage or stopper failure during drawing can lead to accidental exposure for the provider as well as the patient. Therefore, the "at-risk" group extends beyond just those taking the drug at home to include the medical professionals who prepare and administer it, particularly in busy hospital environments where multiple-dose vials are frequently accessed.
Ultimately, the risk is concentrated among individuals who have filled a prescription for NDC 63004-8710-1 or NDC 63004-8710-2 containing lots 1564-107 or 1564-107H. If you are not in this specific medical situation, your risk from this particular recall is effectively zero. However, for those who depend on Acthar Gel, the presence of glass and rubber particles transforms a life-managing medication into a potential source of acute physical harm.
How to tell if you have the recalled item
Identifying the specific vials involved in this recall requires a careful, methodical check of your medication packaging. Because Acthar Gel is a prescription drug used for specific medical conditions, it is likely stored in a dedicated medicine cabinet or kept at home under strict temperature controls. The first and most critical step is to locate the physical box or carton that the vial came in, as well as the vial itself if the outer packaging has been discarded. Do not rely solely on the name of the drug, "Acthar Gel," because this brand name appears on many different products with varying dosages, concentrations, and expiration dates. Only the specific details below match the current FDA recall notice.
Begin by examining the label on the outer cardboard carton. You are looking for a product description that explicitly states "repository corticotropin injection" in a "5 mL multiple-dose vial." Crucially, you must verify the National Drug Code (NDC), which is a unique three-segment number used to identify commercial drugs in the United States. The recalled items carry one of two specific NDCs: 63004-8710-1 or 63004-8710-2. If your vial has a different NDC, it is not part of this recall. Next, turn your attention to the lot number, which is printed prominently on the label. The recall applies specifically to Lot Number 1564-107 and its variation, 1564-107H. It is vital to check both of these designations, as manufacturing lines often produce slightly different lot codes for the same batch run.
Once you have identified the NDC and Lot Number, verify the expiration date. Both recalled lots share the same expiration timeline: 1/31/2027. If your vial has expired prior to this date, or if it expires after, but does not match the specific lot numbers listed above, it is safe from this particular recall issue. You should also confirm that the manufacturer listed on the label is Mallinckrodt ARD LLC, located in Bridgewater, NJ. While the brand is Mallinckrodt, the specific manufacturing entity matters for traceability. If you are unsure where to find these numbers, look for a white rectangular label on the side of the carton or wrapped around the glass vial itself. The text will be small and printed in black, but the NDC and Lot fields are usually standardized in their placement.
If you cannot find the outer carton, inspect the glass vial directly. Acthar Gel is a white to off-white gel, so the contents should not be clear liquid like water; however, the hazard here is particulate matter (glass or stopper pieces) suspended within that gel, which may or may not be visible to the naked eye. Therefore, visual inspection of the liquid alone is not sufficient for safety confirmation. You must rely on the printed label data. Check the vial’s side label for the same NDCs (63004-8710-1 or 63004-8710-2) and Lot numbers (1564-107 or 1564-107H). If you have received this medication from a pharmacy, ask them to verify the lot number on their records against this list. Pharmacists keep digital logs of every item dispensed, which can be faster than searching through physical boxes. Remember, this recall is nationwide, so your location does not change the identification criteria—only the specific product identifiers matter.
If you find a match for any of these criteria, stop using the medication immediately. Do not attempt to filter out particles or shake the vial to mix it, as this could exacerbate the risk of introducing foreign material into the injection site. Keep the vial in its original packaging if possible, and contact your healthcare provider or pharmacist right away. They can help you determine the next steps for replacement therapy and guide you through the return process. This careful verification protects your health by ensuring you are acting on accurate, recall-specific information rather than general assumptions about the brand.
What to do — step by step
If you or a loved one currently has Acthar Gel (repository corticotropin injection) in your medicine cabinet, the most important thing to remember is that panic is not necessary, but prompt action is. Because this recall involves Mallinckrodt Hospital Products Inc. and specifically targets 5 mL multiple-dose vials distributed nationwide, you need to verify exactly what you have before taking any further steps. The FDA has classified this as a Class II recall, which generally means that while the situation is serious enough to require immediate attention, it is unlikely to cause severe or permanent health damage in most cases. However, the presence of particulate matter—specifically glass and stopper pieces—means you must not administer the drug if there is any doubt about its integrity.
Step 1: Stop using the product immediately. If you have a prescription for Acthar Gel and are in the middle of a treatment course, do not simply throw the vial away or skip doses without consulting your healthcare provider. Contact your doctor or pharmacist right away to explain that you possess a potentially recalled unit. They will help you determine if you need an alternative medication to bridge the gap while you resolve this issue. Do not attempt to inspect the vial closely for particles yourself, as handling it unnecessarily increases the risk of accidental injury from broken glass.
Step 2: Verify your specific units. Look at the label on your vials carefully. You are looking for NDC numbers 63004-8710-1 or 63004-8710-2. Crucially, check the lot number. The recall affects Lot #1564-107 with an expiration date of 1/31/2027 and Lot #1564-107H, also expiring on 1/31/2027. If your vials do not match these specific NDCs and lot numbers exactly, they are not part of this recall. It is easy to mix up similar-looking medical packaging, so double-check every digit.
Step 3: Contact the manufacturer for instructions. The official FDA recall notice does not explicitly state a consumer return address or a direct refund process in the summary provided. This is common with pharmaceutical recalls, where the remedy often involves the pharmacy handling the return rather than the patient mailing it directly. You should contact Mallinckrodt ARD LLC, which manufactures the drug for Mallinckrodt Hospital Products Inc., located in Bridgewater, NJ. Your pharmacist can also assist you here; they are required to remove recalled products from their inventory and can guide you on how to return the unused vials for proper disposal or credit.
Step 4: Dispose of the product safely. Do not flush these vials down the toilet or sink, as pharmaceutical waste can contaminate local water supplies. If you cannot return them to your pharmacy immediately, ask a pharmacist about safe drop-off locations in your community. Many pharmacies and law enforcement agencies have designated bins for unused medications. By ensuring the vials are disposed of correctly, you prevent anyone else from accidentally using a contaminated product.
Step 5: Monitor for health issues. While the risk is low, if you recently used a vial from this lot and experience any unusual symptoms—such as pain at the injection site, signs of an allergic reaction, or other unexpected side effects—contact your healthcare provider immediately. Keep a record of when you administered the dose and which lot number was on the vial, as this information will be helpful for medical professionals.
Your refund, repair, or replacement options
When you receive news of a product recall, the immediate concern is often how to resolve the situation without incurring additional costs or facing logistical hurdles. In this specific instance involving Mallinckrodt Hospital Products Inc. and their Acthar Gel (repository corticotropin injection), the official recall notice released on August 6, 2026, does not explicitly detail a standardized remedy such as a direct mail-in refund, a pre-paid return shipping label, or an automatic replacement program. This absence of specific remediation instructions in the public record is not uncommon for Class II drug recalls managed by the FDA, where the primary regulatory focus remains on removing the hazardous product from the supply chain and ensuring patient safety rather than dictating consumer financial restitution.
Because the recall involves a prescription-only medication distributed nationwide to healthcare facilities and pharmacies, the standard pathway for resolution is not through a direct consumer portal but through the professional medical channels where the product was originally dispensed. If you are a patient who has been prescribed this medication, your first and most critical step is to contact the pharmacy or healthcare provider that filled your prescription. They are the entities responsible for executing the recall on behalf of the manufacturer. Typically, in cases where the remedy is not publicly specified as a direct consumer refund, healthcare providers will coordinate with Mallinckrodt ARD LLC to replace the affected vials with safe, non-recalled stock at no cost to you, or they may adjust your billing if the medication was already administered or lost.
It is important to understand that "remedy" in pharmaceutical recalls often differs from consumer goods. Unlike a defective toaster that might be repaired or refunded directly by the manufacturer, prescription drugs are strictly regulated for safety and sterility. Therefore, the "option" available to you is effectively a professional exchange or credit arrangement handled by your medical provider. Do not attempt to return the medication to a retail store drop-box without first confirming with your pharmacist, as improper disposal of corticosteroids can pose environmental and safety risks. Your provider will have access to internal communications from Mallinckrodt ARD LLC regarding lot-specific returns or credits.
If you are a healthcare administrator or pharmacy director managing inventory for NDC 63004-8710-1 (Lot 1564-107) or NDC 63004-8710-2 (Lot 1564-107H), you should contact Mallinckrodt’s customer service or medical affairs department directly for instructions on how to return the affected vials. While specific contact numbers are not listed in this summary, the manufacturer is obligated to provide clear instructions for professional returns. For patients, the peace of mind comes from knowing that your healthcare provider is legally and ethically bound to ensure you receive safe treatment, effectively acting as your intermediary for any financial or logistical resolution related to this recall.
What can happen if you ignore it
If you continue to use the recalled Acthar Gel vials despite knowing about the defect, you are essentially gambling with your vascular health and overall safety. The core issue here is not just that the medication might be slightly less effective—though that is a concern—but that foreign objects are present where only sterile fluid should be. When Mallinckrodt Hospital Products Inc. identified the presence of particulate matter, specifically glass shards and pieces of the rubber stopper, they were identifying physical contaminants that have no place inside your bloodstream or muscle tissue. Ignoring this warning transforms a manageable quality control issue into a potential medical emergency.
The most immediate and dangerous consequence of injecting these vials is the risk of embolism. When you draw medication from a multiple-dose vial, you are pulling liquid through the stopper and out through the needle. If that liquid contains tiny fragments of glass or rubber, those particles travel with the drug into your body. If you are receiving an intravenous injection, these particles can travel directly to your heart, lungs, or brain. Even microscopic glass shards can block small blood vessels, leading to tissue damage, inflammation, or in severe cases, life-threatening complications. For example, a pulmonary embolism occurs when these particles lodge in the lungs, potentially causing shortness of breath, chest pain, and respiratory distress that requires immediate hospitalization.
Even if the injection is administered intramuscularly, as Acthar Gel often is, the risks remain significant. Foreign material introduced into muscle tissue can trigger a severe local inflammatory response. Your body recognizes the glass or rubber as invaders and mounts an immune attack against them. This can result in intense pain at the injection site, swelling, redness, and the formation of granulomas—small areas of inflammation that can persist for weeks or months. These granulomas are not just painful; they can interfere with the absorption of the medication, meaning you might suffer from both the physical side effects of the contaminant and the therapeutic failure of the drug itself.
There is also the risk of infection. While the primary hazard stated is particulate matter, any breach in sterility or the presence of foreign bodies can serve as a nidus for bacterial growth. If contaminants have compromised the integrity of the vial's seal or if the stopper pieces indicate a failure in the sealing process, bacteria may have entered the solution. Injecting contaminated fluid can lead to serious systemic infections, including sepsis, which is a life-threatening response to infection that spreads through the bloodstream.
Finally, consider the psychological and practical toll of ignoring the recall. If you experience an adverse event because you used a recalled product, documenting the cause becomes difficult. You may face delayed treatment because clinicians might not immediately suspect particulate embolism unless you disclose your use of the specific lot numbers. By acting now, you protect yourself from physical harm, avoid unnecessary medical costs associated with treating preventable injuries, and ensure that your treatment plan remains safe and effective. Do not wait for symptoms to appear; the damage from glass or rubber particles can be silent until it is severe.
Staying safe: broader tips
While this specific recall highlights a manufacturing defect involving particulate matter in a pharmaceutical product, the underlying principle of safety for injectable medications and complex drug therapies extends far beyond checking lot numbers. When you are managing a condition that requires repository corticotropin or similar prescription treatments, your daily routine plays a critical role in minimizing risk. The most fundamental step is establishing a trusted relationship with your pharmacist. Pharmacists are not just dispensers of medication; they are accessible safety experts who can help you interpret complex labeling, understand potential interactions with other drugs you may be taking, and provide guidance on proper storage conditions that preserve drug integrity.
Proper storage is often the unsung hero of medication safety. Many injectable medications have strict temperature requirements to maintain their chemical stability and prevent degradation. Even if a product has not been recalled, exposing it to extreme heat, direct sunlight, or freezing temperatures can alter its efficacy or, in rare cases, compromise the integrity of the container and seal. Always store your Acthar Gel exactly as directed on the package insert—typically in a refrigerator at controlled room temperature or chilled, depending on the specific formulation stage. Do not use medication that appears discolored, cloudy (unless specified for this suspension), or contains particles when it should be clear, unless you have confirmed with your healthcare provider that particulate presence is expected for this specific gel formulation.
Another vital aspect of staying safe is proactive communication with your healthcare team. If you notice any unusual changes in how a medication looks, smells, or behaves upon preparation—such as difficulty drawing the dose into a syringe or unexpected resistance—stop immediately. Do not attempt to force the medication through the needle, as this could introduce additional contaminants or cause injury. Report these observations to your doctor or pharmacist right away. They can help determine if the issue is isolated to your specific vial or if it signals a broader need for monitoring.
Finally, make it a habit to regularly check official recall databases, such as those maintained by the FDA and CDC, especially if you manage chronic health conditions. Subscribing to email alerts from these agencies can provide timely notifications about safety issues before they become widespread. Additionally, keep a simple log of your medications, including lot numbers and expiration dates, in a dedicated notebook or secure digital file. This practice not only helps you quickly identify recalled items but also ensures you never use an expired product, which is a common cause of treatment failure. By combining vigilant personal habits with professional medical guidance, you create a robust layer of protection that keeps your health care plan safe and effective.