Bell Pharmaceuticals, Inc recalls CVS Health, Carbamide Peroxide, 6.5%, 0.5 FL Oz (15 mL), a) Bottle (NDC 51316-822-00.); b) Kit (1 BULB, Syringe &

What was recalled

If you have been using ear drops recently from CVS Pharmacy, there is a specific recall you need to be aware of, issued by the U.S. Food and Drug Administration (FDA). This action involves products manufactured by Bell Pharmaceuticals, Inc., which were distributed under the CVS Health brand name. The specific items caught in this recall are labeled as "Carbamide Peroxide, 6.5%," packaged in small 0.5 fluid ounce (15 mL) containers. It is important to understand that this is not a single isolated incident but affects two distinct packaging formats: individual bottles and kits that include application tools. The recall was officially announced on June 25, 2026, covering products distributed nationwide across the United States, with specific mention of distribution patterns in states like Minnesota.

To determine if your product is affected, you must look closely at the National Drug Code (NDC) numbers printed on the packaging. The recall applies to two primary NDCs: NDC 51316-822-00, which corresponds to the standalone bottle, and NDC 51316-823-00, which corresponds to the kit containing one bulb syringe and drops. The manufacturer, Bell Pharmaceuticals, Inc., is located in Woonsocket, Rhode Island, while the distributor is CVS Pharmacy, Inc., based at One CVS Drive in Woonsocket, RI 02895. Because these products are widely available, it is crucial to check the lot numbers directly on your box or bottle, as not all inventory is affected.

The recall specifically targets products with the following lot numbers and expiration dates. For the standalone bottles (NDC 51316-822-00), the affected lots are 1505121, 1504242 (expiration March 2027), and 1505132, 1505182, 1505191, 1505291, 1505331 (expiration April 2027). For the kits (NDC 51316-823-00), the affected lots are 1504231 and 1504311 (expiration March 2027), as well as 1505312 and 1505321 (expiration April 2027). If your product matches these NDCs and lot numbers, it is part of the Class II recall. This classification indicates that while the use or failure of the product may cause temporary health problems or pose a slight threat of a serious nature, it is not classified as a Class I (life-threatening) emergency. However, given the nature of the defect, caution is warranted.

The reason this specific batch was pulled from shelves lies in significant quality control failures during manufacturing. The product was found to be "subpotent," meaning it does not contain the amount of active ingredient stated on the label. In a normal scenario, you would expect the solution to have an assay (concentration) of approximately 6.7%. However, testing revealed that these specific lots had a significantly reduced assay of only about 0.6%. Additionally, the pH level of the solution was found to be low, which could alter how the drops interact with your skin and ear canal. This discrepancy means the product is essentially not working as intended for its primary purpose: softening earwax.

Understanding exactly what you have in your medicine cabinet is the first step in protecting your health. The distribution pattern was nationwide, so even if you bought the item months ago, it could still be one of these defective units if the lot numbers match. CVS Pharmacy, Inc. initiated this recall to ensure that consumers do not rely on a product that is chemically inconsistent and likely ineffective. By identifying the exact NDCs and lot numbers above, you can quickly verify whether your specific bottle or kit is part of this batch.

The hazard, explained

To understand why this recall matters, we first need to look at what Carbamide Peroxide is supposed to do and how this specific batch fails to perform that function. Carbamide peroxide is a common chemical compound used in earwax removal kits. When it comes into contact with moisture, such as the natural fluids in your ear canal, it breaks down into two primary active ingredients: urea and hydrogen peroxide. The hydrogen peroxide acts as an oxidizing agent, creating bubbles that mechanically break up hardened wax, while the urea helps to soften the cerumen (earwax) so it can be flushed out more easily. For this process to work safely and effectively, the solution must maintain a specific concentration—typically around 6.5% in over-the-counter products—and a balanced pH level that is gentle enough for the delicate skin of the ear canal.

In the case of the Bell Pharmaceuticals recall involving CVS Health’s Carbamide Peroxide kits and bottles, the substance has suffered from two critical chemical failures: it is "subpotent" due to a significantly reduced assay and an abnormal pH level. The term "assay" refers to the measurement of the actual amount of active ingredient present in the product. While the label claims the product contains 6.5% carbamide peroxide, testing revealed that the actual concentration was drastically lower, measured at approximately 0.6%. This is a massive discrepancy. Essentially, you are getting less than one-tenth of the strength advertised on the box. Because the active ingredient is so weak, the solution will not generate enough oxygen bubbles to soften or dislodge impacted earwax. If you use this product expecting it to work, you will likely find that it does nothing, leaving your hearing obstructed and potentially leading you to try more aggressive, unsafe methods to clear your ears.

The second part of the hazard involves the pH level. The recall notice specifies a "low pH," meaning the solution is more acidic than intended. The skin inside the ear canal is sensitive and has a natural protective barrier. Products designed for this area are carefully formulated to be isotonic and pH-balanced to prevent irritation, stinging, or chemical burns. A low-pH solution can disrupt the skin’s natural barrier, causing inflammation, redness, itching, or even open sores in the ear canal. This is particularly risky if you already have a minor scratch or irritation from using cotton swabs or other tools. Applying an acidic, ineffective solution to compromised skin can lead to secondary infections or prolonged discomfort.

Combining these two factors creates a scenario where the user receives no therapeutic benefit while simultaneously risking physical harm. The low potency means you waste time and money on a product that cannot solve your problem, while the incorrect pH introduces a chemical irritant directly into a sensitive body cavity. This is classified as a Class II recall by the FDA, which indicates that use of the product may cause temporary medical problems or pose a slight threat of a serious nature, depending on the severity of the irritation and the duration of exposure.

Who is most at risk

The primary group affected by this recall consists of individuals who have purchased or are currently using specific bottles and kits of CVS Health Carbamide Peroxide 6.5% ear drops. These products, distributed nationwide by CVS Pharmacy, Inc., are commonly found in pharmacy aisles and are typically used for the temporary relief of earwax buildup. If you have one of the identified lot numbers on hand—specifically bottles or kits with NDC codes 51316-822-00 or 51316-823-00, manufactured by Bell Pharmaceuticals, Inc.—you fall directly into the category of people impacted by this notice. The distribution pattern covers the entire United States, meaning that anyone who bought these items from a CVS location or potentially through other retail channels nationwide could be holding a subpotent version of the medication.

While the recall is classified as a Class II event, indicating that use of the product may cause temporary health problems or pose only a slight threat of serious nature, the implications for specific users warrant careful attention. The core issue here is not immediate toxicity, but rather therapeutic failure. Because the product has a significantly reduced assay (approximately 0.6% compared to the expected 6.5%) and low pH, it may fail to effectively soften or remove earwax. For most healthy adults, this might simply mean the treatment did not work as advertised, leading to continued discomfort from impacted cerumen. However, for individuals who rely on these drops to manage chronic earwax issues without immediate access to professional care, the risk extends beyond mere inconvenience.

Certain populations may be more vulnerable to the consequences of using this ineffective product. Older adults, for instance, often experience more frequent and stubborn earwax impaction due to natural changes in ear canal skin and gland function. If they use these subpotent drops expecting relief, they may delay seeking proper medical evaluation, allowing the wax to harden further or become more difficult to remove safely. Similarly, individuals with sensitive ear canals or those who have previously experienced irritation from other treatments might be at risk of worsening their condition if they attempt to compensate for the lack of efficacy by using higher volumes or more frequent applications, potentially leading to physical trauma or secondary infection.

Parents and caregivers are also in a critical position here. If children are receiving these drops for earwax management, the failure of the treatment could mask underlying issues or prolong discomfort. While the product itself is not toxic, the psychological impact of continued pain or hearing muffled sounds can affect a child’s daily activities, including sleep and concentration at school. Furthermore, because the pH level is abnormally low, there is a theoretical risk that the solution could cause stinging or irritation upon application, which might be particularly distressing for younger users who cannot articulate their discomfort clearly. It is essential to recognize that while the hazard is primarily one of underperformance, the real-world impact on health and comfort can be significant for those depending on this common over-the-counter remedy.

How to tell if you have the recalled item

Before you take any action or contact customer support, the most critical step is confirming that the bottle or kit in your medicine cabinet matches the specific items listed in the FDA recall notice. Because this recall involves over-the-counter ear care products distributed by CVS Pharmacy, Inc., and manufactured by Bell Pharmaceuticals, Inc., it is easy to accidentally confuse recalled units with similar-looking, safe products on the shelf. To ensure you are identifying the correct item, you need to examine two primary pieces of packaging: the outer cardboard box and the label on the container itself.

First, look at the product name. You are searching for "CVS Health, Carbamide Peroxide, 6.5%." This recall affects two distinct formats: a standalone bottle and a kit that includes a bulb syringe. If you have the standalone bottle, it must be exactly 0.5 FL Oz (15 mL). If you have the kit, it should contain one bulb syringe along with the drops. It is vital to check the National Drug Code (NDC) printed on the label, as this is the unique fingerprint for these specific units. The recalled bottles carry the NDC 51316-822-00. The recalled kits carry the NDC 51316-823-00. If your product has a different NDC number, it is not part of this recall.

Next, you must verify the lot number and expiration date, as only specific manufacturing batches are affected. For the standalone bottles (NDC 51316-822-00), check for Lot numbers starting with 1505121, 1504242 (both expiring March 2027); or 1505132, 1505182, 1505191, 1505291, 1505331 (all expiring April 2027). For the kits (NDC 51316-823-00), look for Lot numbers 1504231 and 1504311 (expiring March 2027); or 1505312 and 1505321 (expiring April 2027). If your lot number is not listed above, or if the expiration date does not match these specific months in 2027, your product is safe to use.

You can find this information printed on the side or bottom of the cardboard box and embossed or printed directly onto the plastic bottle or kit components. The distribution pattern for this recall is nationwide across the United States, so purchasing location does not rule out the product. However, the distributor is specifically CVS Pharmacy, Inc., located in Woonsocket, RI. If you are unsure about the lot number due to faded printing, do not guess. Take a clear photo of the label and consult the official recall notice or contact the manufacturer directly for verification.

What to do — step by step

If you have been using CVS Health Carbamide Peroxide for earwax removal, it is important to approach this situation with calm attention rather than panic. Because the FDA has identified that these specific lots contain significantly less active ingredient than advertised—sometimes as low as 0.6% instead of the expected 6.5%—the primary risk is not immediate toxicity, but rather treatment failure. Essentially, the product may not work as intended, which could allow earwax to build up or an underlying ear condition to go untreated. Since the official recall notice from Bell Pharmaceuticals and the FDA does not currently list a specific remedy such as a mail-back return program, a direct refund process, or a replacement kit, you must take proactive steps to ensure your health and resolve the issue on your own.

1. Stop using the product immediately. The first and most critical step is to discontinue use of any CVS Health Carbamide Peroxide 6.5% in the affected packaging. This applies to both the individual bottles (NDC 51316-822-00) and the kit versions that include a bulb, syringe, and drops (NDC 51316-823-00). Continuing to use a sub-potent product will not harm you in a toxic sense because the chemical is relatively mild, but it wastes time when you need effective relief. If you were relying on this drop for ear cleaning before a medical appointment or while experiencing discomfort, know that the lack of effect is due to the manufacturing error, not your body’s reaction.
2. Check your lot numbers carefully. Not every bottle of CVS Health Carbamide Peroxide is part of this recall. You must verify that your product matches one of the specific lots listed by Bell Pharmaceuticals. For the bottles, check for lots 1505121, 1504242 (expiring March 2027), and lots 1505132, 1505182, 1505191, 1505291, 1505331 (expiring April 2027). For the kits, check for lots 1504231, 1504311 (expiring March 2027), and lots 1505312, 1505321 (expiring April 2027). If your lot number is not on this list, your product is safe to use according to the current recall data.
3. Contact CVS Pharmacy directly for a resolution. Since the official FDA recall facts do not state a central remedy or provide a dedicated hotline for refunds, your best path forward is to go to the store where you purchased the item. Bring the product with you, along with your receipt if you have it. Explain that you are returning a Class II recalled drug due to potency issues. Most major pharmacy chains like CVS have internal policies for handling defective or recalled pharmaceuticals, even if the manufacturer has not yet issued a nationwide return instruction. They may offer you an exchange for a different brand of earwax remover or store credit, depending on their current stock and policy.
4. Consult your healthcare provider if symptoms persist. If you were using this product to manage earwax impaction or discomfort, and it did not work because of the low potency, do not simply keep trying with the same bottle. Instead, speak with your doctor or an audiologist. They can safely remove any built-up wax using professional tools and advise you on whether you need a different type of treatment. Do not attempt to use other over-the-counter drops without checking with a pharmacist, as some ingredients might interact poorly if your ear canal is already irritated.
5. Monitor for broader updates. Recall situations can evolve. While the current date of this notice is June 25, 2026, and no remedy is stated yet, Bell Pharmaceuticals or the FDA may issue an update later adding a return label or a specific contact number. Keep an eye on the FDA’s official website or the CVS Pharmacy website for any announcements regarding this specific NDC numbers. If you experience any unusual symptoms after using the product, report them to your doctor and consider filing a MedWatch report with the FDA, though in this case, the main issue is efficacy rather than adverse reaction.

By taking these steps, you protect your health and ensure that you are not left waiting for a remedy that may not be centrally organized. The key is to stop using the ineffective product, verify your lot number, and seek alternative care or a store-level resolution immediately.

Your refund, repair, or replacement options

When you encounter a product recall, the most pressing question is often, "What do I get back for my trouble?" In this specific instance involving Bell Pharmaceuticals and CVS Health, the official FDA recall documentation presents a somewhat unusual scenario regarding consumer restitution. The record explicitly states that the remedy is "not stated." While this might initially feel like a dead end or leave you wondering if you have been left without recourse, it is important to understand what this means in the context of regulatory compliance and corporate responsibility.

First, it is crucial to clarify what Bell Pharmaceuticals cannot do for you. Because the specific remedy terms are not listed in the public notice, we cannot direct you to a specific online portal, a dedicated toll-free hotline exclusively for refunds, or a mail-in address for sending back defective units. There is no official instruction here to "mail this back for a full credit" or "visit the website to claim your voucher." Any suggestion that you should wait for a letter in the mail or that there is a universal automated process is not supported by the current facts. The absence of stated terms means there is no standardized, one-size-fits-all procedure mandated by the agency at this moment.

However, "not stated" does not mean "no options." It simply means the path to resolution is not codified in the general public alert. Your primary avenue for resolving this issue remains the point of purchase. Since CVS Pharmacy, Inc. distributed these items, they are generally held accountable for customer satisfaction and product integrity. In typical retail practices, even when a manufacturer’s recall notice is vague on financial restitution, the retailer often steps in to handle the direct interaction with the consumer. This is because the transaction occurred within their ecosystem, and they have the records of your purchase.

To navigate this, you should take a proactive but calm approach. Gather any proof of purchase you have, such as a receipt, bank statement, or loyalty program record. Then, contact the customer service department of CVS Pharmacy directly. You do not need to guess which department to call; their main customer service line is the appropriate starting point. Explain that you purchased a recalled lot of Carbamide Peroxide 6.5% and that the manufacturer’s recall notice does not specify the remedy. Ask them specifically what their policy is for this situation.

In many cases, retailers will offer a straightforward replacement of the same item if it is still available, or they may issue a refund to your original form of payment. If you bought the item in-store, they might ask you to bring the physical bottle or kit back to the store for verification before processing the credit. If you purchased it online, they may initiate a return shipping label or simply credit your account without requiring the physical return, depending on their internal risk assessment. By contacting CVS directly, you are bypassing the ambiguity of the manufacturer's notice and dealing with the entity that has the direct relationship with your wallet.

It is also wise to document your interaction. Keep notes of who you spoke with, the date, and any reference numbers provided by customer service. This creates a paper trail in case there are delays or disputes later on. While the recall notice does not guarantee a specific outcome, your rights as a consumer to receive safe products remain intact, and the retailer is your best resource for restoring that balance.

What can happen if you ignore it

Staying safe: broader tips

When dealing with over-the-counter medications and topical treatments, especially those involving chemical compounds like carbamide peroxide, vigilance is your best defense. While manufacturers and regulatory agencies work hard to ensure product integrity, the supply chain is complex and errors can occasionally slip through. The most effective way to protect yourself is to make checking for recalls a regular habit, rather than a reactive measure taken only after hearing news reports. You can sign up for email alerts directly from the FDA’s public dashboard or download their official safety app. These tools provide timely updates on drug withdrawals, allowing you to act before a potential issue affects your health.

Beyond monitoring recall lists, understanding how to store these products correctly is critical for maintaining their efficacy and safety. Many topical medications are sensitive to temperature fluctuations, light exposure, and humidity. Storing them in cool, dry places away from direct sunlight helps preserve the chemical stability of the active ingredients. If a product’s pH balance or concentration degrades due to improper storage, it may not only lose its therapeutic value but could also cause unexpected skin irritation or reduced effectiveness when used. Always check the expiration date on the packaging; even if a recall has not been issued for your specific lot, an expired product should never be used, as the chemical composition can change over time.

It is also wise to keep a simple log of the medications you have at home, noting the brand, NDC (National Drug Code), and lot numbers. This practice makes it much easier to verify your inventory against any future safety alerts. If you are purchasing these items in bulk or for family use, consider sharing verification checklists with other household members. This ensures that everyone is aware of which products are currently under review.

Finally, never hesitate to consult a pharmacist or healthcare provider if you have questions about a product’s suitability for your specific health needs. They can help you identify safer alternatives or verify that a recalled item has been properly replaced. By staying informed and proactive, you transform passive consumption into active health management, ensuring that the products you use are both safe and effective.