Teva Pharmaceuticals USA, Inc recalls traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactured in Croatia By: Pliva Hrvatska d.o.o,

What was recalled

The U.S. Food and Drug Administration (FDA) has issued a recall involving a specific pharmaceutical product manufactured by Teva Pharmaceuticals USA, Inc. This action centers on a batch of prescription-only medication known as TraZodone Hydrochloride Tablets, USP, specifically in the 50 mg dosage strength. To ensure you can identify whether your current supply is affected, it is crucial to look at the precise labeling and packaging details associated with this recall event.

The product in question is packaged as a bottle containing exactly 100 tablets. These tablets are manufactured by Pliva Hrvatska d.o.o., located in Zagreb, Croatia, on behalf of Teva Pharmaceuticals, which is headquartered in Parsippany, New Jersey. The specific National Drug Code (NDC) number for this recalled lot is 50111-560-01. If you are checking your medicine cabinet, the NDC is typically printed on the label and serves as a unique identifier for the drug’s labeler, product, and package size.

Beyond the NDC, the most critical piece of information to verify is the lot number. The recall applies specifically to Lot 1394026. Additionally, you should check the expiration date printed on the bottle, which for this particular lot is listed as February 2028. It is important to note that while the expiration date may seem far out, the presence of a safety hazard within the manufacturing process necessitates this recall regardless of how long the medication would typically remain potent.

This product was distributed nationwide across the United States, meaning it could have been sold in pharmacies, hospitals, or clinics in any state. However, the specific records for this recall action highlight its distribution pattern and regulatory oversight from New Jersey, where Teva Pharmaceuticals is based. The classification of this recall as a Class II indicates that use of or exposure to the violative product may cause temporary or medically reversible serious adverse health consequences, or where the probability of serious adverse health consequences is remote.

The recall was officially dated August 24, 2026. At this time, the FDA has not yet stated a specific remedy, such as a refund or replacement program, in the provided facts. Consumers who possess this exact combination of brand (Teva), drug name (TraZodone Hydrochloride Tablets, USP, 50 mg), NDC (50111-560-01), and Lot number (1394026) should take immediate steps to verify their inventory against this description to ensure their safety.

The hazard, explained

When we talk about a "foreign object" or "foreign tablet" recall in the context of pharmaceuticals, it is easy to imagine a simple mix-up, like finding a loose pill at the bottom of a bottle. However, the reality of this specific incident involving Teva Pharmaceuticals’ TraZodone Hydrochloride Tablets is far more complex and potentially dangerous than a mere inconvenience. The core issue here is not just that an extra item is present, but that it is an unidentified pharmaceutical agent mixed into a sterile, controlled manufacturing environment. This represents a profound breach in the chain of custody and quality control that ensures every single tablet you swallow is exactly what the prescription dictates.

To understand why this is so serious, we must look at how TraZodone works. TraZodone is a psychoactive medication primarily used to treat depression and insomnia. It functions by altering the levels of certain natural substances in the brain, specifically serotonin and norepinephrine. Because it affects these critical neurotransmitters, its dosage must be precise. If you are taking 50 milligrams of TraZodone as prescribed, your body is expecting a very specific chemical interaction. Introducing an unknown foreign tablet disrupts this delicate balance entirely. You are no longer just taking your medication; you are inadvertently consuming another drug whose identity, potency, and side effects are completely unknown to you.

The physical mechanism of harm in this scenario is twofold: accidental overdose and dangerous drug interactions. If the foreign tablet is another sedative or central nervous system depressant, combining it with TraZodone can lead to excessive drowsiness, respiratory depression, or even coma. On the other hand, if the foreign tablet is a stimulant or an antidepressant from a different class (such as an SSRI), mixing it with TraZodone could trigger Serotonin Syndrome, a potentially life-threatening condition characterized by agitation, confusion, rapid heart rate, and high blood pressure. Without knowing what the foreign object is, you cannot assess your risk level.

Furthermore, this hazard highlights a failure in the manufacturing process itself. TraZodone tablets are produced under strict Good Manufacturing Practices (GMP) to ensure purity and uniformity. The presence of foreign tablets suggests that during the compression, coating, or packaging phase, an unrelated product was inadvertently introduced into the production line. This could have happened due to equipment malfunction, human error in cleaning procedures between batches, or a failure in automated sorting systems. Regardless of how it happened, the result is a product that is physically contaminated at the molecular level with another entity. For a patient relying on this medication for mental health stability, the psychological distress of not knowing what you are ingesting adds an additional layer of harm to the physical risks.

In summary, the hazard here is not merely about getting the wrong dose; it is about the unpredictable and potentially catastrophic interaction between your prescribed treatment and an unknown variable. The "foreign" nature of the tablet means it has no label, no known expiration date, and no verified safety profile in this context. This uncertainty is what transforms a simple manufacturing error into a significant public health concern, necessitating a Class II recall to remove these units from circulation before they can cause serious injury or adverse medical outcomes.

Who is most at risk

When we talk about who is "at risk" in a recall involving pharmaceuticals, it is important to distinguish between two very different types of danger. In this specific situation with Teva Pharmaceuticals' recalled TraZodone Hydrochloride Tablets, the primary concern is not necessarily an overdose from taking too much medication, but rather the accidental ingestion of an entirely wrong drug. The hazard here is the presence of foreign tablets or capsules within a bottle that should contain only one specific type of prescription. This means that anyone who has been prescribed TraZodone for conditions such as major depressive disorder or insomnia could potentially take a pill intended for someone else, or a completely different class of medication altogether.

The individuals most directly at risk are those who have actively filled this specific prescription and are currently taking it. Because the distribution was nationwide, this includes patients across all fifty states who received Lot 1394026 from any pharmacy in the country. However, within that broad group, certain demographics face heightened vulnerability due to how their bodies process medications and how they manage their health regimens.

Elderly patients are often at greater risk when foreign substances enter their medication supply. Older adults frequently take multiple medications daily, a practice known as polypharmacy. This complexity increases the likelihood of confusion, making it harder to notice subtle changes in pill appearance or texture. Furthermore, the elderly body metabolizes drugs differently and is often more sensitive to side effects. If a foreign tablet contains a potent blood thinner, a heart medication, or a strong sedative, an older adult’s system may react with severe dizziness, bleeding risks, or dangerous drops in blood pressure that could lead to falls and serious injury.

Children and adolescents are another critical group at risk, particularly if they live in households where multiple family members take different prescriptions. If this bottle was stored in a shared medicine cabinet or nightstand, a child might mistake the foreign tablet for their own medication or even a candy-like pill. Children have lower body weights, meaning even a small amount of an incorrect drug can lead to toxic levels in the bloodstream much faster than in an adult. The effects could range from unexpected drowsiness and confusion to more severe neurological or cardiac complications, depending on what the foreign substance is.

Additionally, individuals with pre-existing health conditions that are sensitive to specific drug interactions should be extra cautious. TraZodone itself affects serotonin levels in the brain. If a foreign capsule contains another serotonergic drug, there is a risk of serotonin syndrome, a potentially life-threatening condition. Similarly, if the foreign tablet contains a medication that interacts poorly with heart rhythm or liver function, patients with those underlying conditions could face acute health crises. Therefore, while anyone who took this lot is at risk of taking the wrong medicine, those with complex medical histories, the elderly, and children require immediate attention and verification to ensure no accidental ingestion has occurred.

How to tell if you have the recalled item

Before you take any action or contact the manufacturer, you must be absolutely certain that the medication in your cabinet matches the specific batch identified in this recall. Because this is a Class II recall involving potential contamination with foreign tablets or capsules, relying on general knowledge of the drug is not enough. You need to verify the exact physical details against the official record. The process begins by locating your prescription bottle and examining the label for several critical pieces of information that act as unique identifiers.

The most important identifier is the National Drug Code (NDC). For this specific recall, you are looking for NDC 50111-560-01. This code is a unique three-segment number assigned to each drug listing and is printed clearly on the side or back of the prescription label. If your bottle does not display this exact NDC sequence, it is likely not part of this specific distribution batch, but you should still verify other details for peace of mind.

Next, check the lot number. This alphanumeric code tracks the specific production run of the medication and is crucial for determining if your unit was affected by the manufacturing issue. The recalled lot number is 1394026. This number is typically printed near the expiration date or on the main body of the label. If the lot number differs, your tablets are safe from this particular contamination event.

You must also verify the strength and quantity of the medication. The recall applies specifically to TraZODone Hydrochloride Tablets, USP, 50 mg. Ensure that the dosage strength listed on your bottle is exactly 50 milligrams. Additionally, check the container size; this recall involves bottles containing 100 tablets. If you have a different count or strength, it is not included in this notice.

While less commonly checked, verifying the manufacturer details can provide further confirmation. The label should indicate that the product was manufactured by Pliva Hrvatska d.o.o. in Zagreb, Croatia, for Teva Pharmaceuticals USA, Inc., located in Parsippany, NJ. Although Teva is the brand name you recognize, the foreign manufacturing origin is part of the specific record for this contaminated batch.

Finally, look at the expiration date. The recalled lot has an expiration date of February 2028 (Exp. 02/2028). While a different expiration date does not automatically rule out other issues, it helps confirm whether you are holding the exact unit described in the FDA report. If your bottle matches all these criteria—NDC 50111-560-01, Lot 1394026, 50 mg strength, 100 count, and Exp. 02/2028—you have the recalled item. Do not use it. Keep it sealed in its original container until you follow the remedy instructions provided by Teva Pharmaceuticals or your pharmacy.

What to do — step by step

If you have been prescribed or possess the recalled Teva Pharmaceuticals USA, Inc. traZODone Hydrochloride Tablets, USP 50 mg, it is important to act with care and precision. The primary concern here is not just the efficacy of the medication, but the physical integrity of what you are putting into your body. Because this recall involves the presence of foreign tablets or capsules within the bottle, the risk is one of accidental ingestion of an unknown substance. This could range from a harmless mix-up in manufacturing to a serious health hazard depending on what that foreign item actually is. Therefore, your immediate actions should prioritize safety and verification.

1. Stop taking the medication immediately. Do not consume any more pills from this specific bottle. Even if you have only taken one or two doses so far, the presence of foreign material suggests a breakdown in quality control that could affect every subsequent dose. It is better to miss a single dose than to risk ingesting an unknown compound. If you are concerned about missing your dose due to anxiety or other conditions, please contact your healthcare provider right away to discuss temporary alternatives. Do not try to "sort through" the pills yourself to find the good ones, as this can be dangerous and is not a substitute for professional medical advice.
2. Secure the product and do not discard it yet. Keep the bottle in a safe place where children or pets cannot access it. Do not throw the medication down the toilet or into the trash just yet. The FDA and the manufacturer need to be able to verify the lot number and expiration date to confirm that your specific bottle is part of this recall. If you have already thrown it away, note the NDC (50111-560-01) and Lot Number (1394026) from any remaining packaging or receipts.
3. Contact your pharmacy or healthcare provider. Since the remedy details are not explicitly stated in the current recall notice, the standard procedure for pharmaceutical recalls of this nature is to return the product to the point of dispensing. Call the pharmacy where you picked up the prescription. They can verify if they have records of this lot number and guide you on how to return it safely. In many cases, pharmacies will arrange for a safe disposal or credit your account once the bottle is returned. Do not attempt to mail this back to Teva Pharmaceuticals directly unless explicitly instructed by your pharmacist, as improper handling of controlled substances or prescription drugs can be illegal.
4. Monitor for any adverse effects. If you have already ingested pills from this lot and feel unwell, contact Poison Control immediately at 1-800-222-1222 or seek emergency medical attention. Provide them with the NDC and lot number if possible. Even if you feel fine, keep an eye on your body for any unusual symptoms over the next few days.

While the recall notice does not specify a direct refund process from the manufacturer, your pharmacy is generally obligated to help resolve the issue. They may offer a replacement from a different lot or a full refund, depending on their inventory and state laws. Always keep your receipt or prescription record handy to facilitate this process.

Your refund, repair, or replacement options

When a recall involves a pharmaceutical product like the Teva Pharmaceuticals traZODone Hydrochloride Tablets, the concept of a traditional "refund" or "replacement" works differently than it does for a defective toaster or a pair of shoes. It is important to approach this situation with patience and clarity, understanding that your primary goal right now is safety and proper disposal, rather than simply getting your money back immediately. The official recall facts provided for this specific Class II recall do not explicitly state the remedy terms, such as whether Teva Pharmaceuticals has issued a direct reimbursement policy or a prepaid shipping label for returns. Because these details are not stated in the current record, you should not assume that a standard consumer return process applies here.

In most drug recalls managed by the FDA and executed by manufacturers like Teva, the company’s primary directive is to stop the distribution of the affected product and ensure it does not end up in consumers' hands. While companies often do arrange for the return of the recalled inventory to their facilities for destruction, they may or may not cover the cost of shipping or provide a direct monetary refund to the individual patient. Instead, the typical path forward involves contacting the pharmacy where you originally filled the prescription. Pharmacies are generally equipped to handle these situations more smoothly than individual consumers because they have established protocols with manufacturers and distributors.

If you purchased this medication directly from a brick-and-mortar pharmacy or an online retailer, your first step should be to call them. Explain that you possess a unit of the recalled product (NDC 50111-560-01, Lot 1394026). The pharmacy can then advise you on their specific process. They may offer to void the charge on your credit card or insurance claim, effectively acting as your refund mechanism. In some cases, they might allow you to exchange the recalled batch for a new, safe batch of the same medication if it is available and if your healthcare provider approves. This exchange ensures you do not miss any doses of your treatment while maintaining financial fairness.

If you cannot reach the pharmacy or prefer to contact the manufacturer directly, you should look for the customer service information provided in the official FDA recall notice or on Teva Pharmaceuticals’ website. However, since the specific contact details and remedy instructions are not stated in the provided recall facts, you must rely on the official channels announced by the FDA for this specific event. Do not attempt to mail the product back without explicit instructions, as improper handling of controlled substances or prescription drugs can pose safety risks. The "remedy" here is largely about cessation of use and safe disposal, guided by your healthcare provider’s advice on how to maintain your treatment plan without interruption.

Ultimately, while financial restitution is a valid concern, the immediate priority is ensuring that the foreign tablets or capsules potentially present in this lot do not reach your body. The lack of stated remedy terms does not mean help is unavailable; it means the process is likely managed through your healthcare provider and pharmacy network to ensure safety compliance. Stay calm, keep the bottle for reference, and let the professionals guide you through the next steps.

What can happen if you ignore it

Staying safe: broader tips

When dealing with prescription medications, especially those distributed in bulk or manufactured across international supply chains, vigilance is your most effective tool for safety. While the specific recall of Teva Pharmaceuticals’ traZODone Hydrochloride Tablets highlights a rare but serious manufacturing defect—foreign material present in the bottle—the broader lesson applies to how we manage all pharmaceutical products at home. The first and most critical habit is to treat every prescription bottle as a secure, sealed environment until you are ready to use it. Never transfer pills into unmarked daily organizers or loose containers without first verifying the label matches your current prescription exactly. This simple step prevents accidental ingestion of incorrect dosages or medications intended for other household members, a common source of medication errors that can be just as dangerous as any manufacturing defect.

Regularly checking for product recalls is another essential practice that many consumers overlook until it is too late. Government agencies like the FDA and the Consumer Product Safety Commission (CPSC) issue alerts when hazards are detected, but these notices only help you if you are actively monitoring them. Consider subscribing to email alerts from these agencies or using reputable third-party safety apps that push notifications for specific drug classes or product categories. By staying informed, you transform passive consumption into active safety management. This is particularly important for medications produced in facilities overseas, where quality control processes may differ slightly from domestic standards, making the importance of verifying lot numbers and expiration dates even more pronounced.

Furthermore, proper storage and disposal of medications play a significant role in maintaining their integrity and preventing accidental exposure. Store all medicines in a cool, dry place away from direct sunlight and humidity, which can degrade active ingredients over time. Keep them out of reach of children and pets by using locked cabinets or high shelves, never relying on the bottle cap’s child-resistant feature as your sole safeguard. When it comes to disposal, never flush medications down the toilet unless the label explicitly instructs you to do so. Instead, utilize local drug take-back programs offered by pharmacies, law enforcement agencies, or community events. These programs ensure that unused or expired drugs are destroyed safely, preventing them from entering the water supply or being misused by others. By adopting these general safety habits, you create a robust personal defense system against both specific product defects and broader medication-related risks.

• Verify Before You Use: Always cross-check the National Drug Code (NDC), lot number, and expiration date on your bottle against official recall lists before taking any new prescription.
• Secure Storage: Keep medications in their original, labeled containers in a locked or high-up location to prevent accidental ingestion by children or pets.
• Safe Disposal: Use FDA-approved take-back locations to dispose of unused or expired drugs, ensuring they do not harm the environment or fall into the wrong hands.
• Stay Informed: Sign up for recall alerts from the FDA and CPSC to receive timely updates on safety issues affecting your household products.