Aurobindo Pharma USA Inc recalls Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279

What was recalled

The U.S. Food and Drug Administration (FDA) has initiated a Class II recall affecting a specific pharmaceutical product distributed by Aurobindo Pharma USA Inc. This action involves Dicyclomine Hydrochloride Capsules, USP, specifically the 10mg strength formulation. The recall is limited to a precise batch of inventory: one thousand (1,000) bottles of this prescription-only medication. While the manufacturer and distributor are based in the United States, the product itself was manufactured in India, highlighting the global nature of modern pharmaceutical supply chains. The specific distribution details identify the distributor as Aurobindo Pharma USA, Inc., located at 279 Princeton-Hightstown Road in East Windsor, New Jersey, with the postal code 08520.

To help you verify whether you possess the affected item, it is crucial to check the National Drug Code (NDC) and the batch number printed on your medication bottle. The recalled product carries the NDC 59651-719-99. Furthermore, you must look for the specific batch identifier DMC125018A. It is also important to note the expiration date associated with this lot, which is listed as July 2027 (07/2027). If your bottle matches all these identifiers—the correct NDC, the exact batch number, and the distribution by Aurobindo Pharma USA Inc.—it falls within the scope of this recall. The medication was distributed nationwide across the United States, meaning that patients in any state could potentially have been affected by this specific lot.

This recall was officially reported on July 23, 2026 (2026-07-23). A Class II classification by the FDA indicates that the use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. In this case, the issue stems from a manufacturing defect rather than contamination or incorrect dosage ingredients. The core problem is a "shortfill," which means the bottles do not contain the full quantity of capsules they are supposed to hold. More critically, there have been reports of empty capsules within these bottles. This is a significant quality control failure because it suggests that the filling process did not properly deposit the active pharmaceutical ingredient into every capsule shell. For patients relying on a consistent dose of Dicyclomine Hydrochloride for conditions such as irritable bowel syndrome (IBS), receiving an empty capsule means they are missing their prescribed treatment entirely, which can lead to uncontrolled symptoms and discomfort. The recall is a proactive measure by the company and the FDA to remove these defective products from circulation before they cause further disruption to patient care.

Understanding exactly what was recalled helps in isolating the issue. It is not a blanket recall of all Dicyclomine Hydrochloride products or all products made by Aurobindo Pharma. It is strictly limited to the 1,000 bottles of the 10mg capsules with NDC 59651-719-99 and Batch # DMC125018A. If you are using a different strength (such as 20mg) or a different batch number from a different manufacturer, this specific recall does not apply to your medication. However, because the distribution was nationwide, it is essential to take the time to check your bottle against these precise details rather than assuming safety based on brand name alone.

The hazard, explained

When you look at a standard prescription bottle of medication, there is an implicit contract between the manufacturer and the patient: what you see on the label is exactly what you get in the bottle. In this specific recall involving Aurobindo Pharma USA Inc., that contract has been broken due to a manufacturing defect known as a "shortfill." This term might sound technical, but it describes a very tangible physical failure. The bottles of Dicyclomine Hydrochloride Capsules, USP, 10mg were filled with fewer capsules than the label claims they should contain. While the bottle may appear full at a glance, or perhaps only slightly lighter than usual, the critical issue is that the count is incorrect. In some reported instances, this defect has been severe enough to result in reports of empty capsules or entirely empty bottles reaching consumers.

The harm here is not caused by a toxic ingredient or a chemical contamination, which are common fears when hearing about drug recalls. Instead, the danger lies in the unpredictability of your treatment. Dicyclomine is an antispasmodic medication primarily used to treat irritable bowel syndrome (IBS). It works by relaxing the muscles in your gut to reduce cramping and pain. For many patients, managing IBS requires a very precise dosage schedule. If you are prescribed a specific number of capsules per day, expecting a certain duration for your supply, receiving fewer units than anticipated can lead to an unintentional gap in your therapy.

This gap is where the physical risk materializes. If you run out of medication earlier than expected because the bottle was shortfilled, you may inadvertently skip doses. For chronic conditions like IBS, inconsistent dosing can lead to a sudden return of severe symptoms. This might mean experiencing unexpected abdominal cramping, bloating, or urgent bowel movements that disrupt your daily life and physical comfort. In more acute scenarios, if a patient relies on this medication to prevent severe spasms during travel or important events, having less medication than expected could leave them vulnerable to painful episodes without the necessary relief.

Furthermore, the report of "empty capsules" adds a layer of confusion and potential waste. If you are opening bottles expecting a full course of treatment and finding them empty or nearly so, it creates a logistical nightmare for managing your health. You might delay seeking help while trying to figure out if the bottle is defective, during which time your condition could worsen. The core issue is reliability: you cannot trust the volume on the label to reflect the reality in your hand. This uncertainty undermines your ability to plan your care effectively, turning a routine prescription into a source of stress and potential health instability.

Who is most at risk

The primary group affected by this recall consists of individuals who have been prescribed Dicyclomine Hydrochloride capsules to manage symptoms associated with Irritable Bowel Syndrome (IBS). This medication is a common antispasmodic used to relax the muscles in the stomach and intestines, helping to reduce cramping and abdominal pain. Because the issue involves shortfilled bottles—meaning some containers may contain fewer capsules than expected—or reports of empty capsules being received, the risk here is not one of toxic exposure or harmful chemical reaction. Instead, the danger stems from a failure of treatment reliability. For patients relying on this specific dosage to maintain symptom control, receiving an incomplete supply can lead to unexpected gaps in their therapeutic regimen.

While anyone with a prescription for this lot could be impacted, certain populations may find themselves disproportionately vulnerable to the consequences of this supply error. Elderly patients, who frequently manage IBS or similar gastrointestinal conditions, often have more complex health profiles and may be taking multiple medications simultaneously. For these individuals, a sudden interruption in their antispasmodic therapy can lead to a rapid return of severe symptoms, such as intense abdominal cramping or diarrhea, which can quickly lead to dehydration or electrolyte imbalances. Because older adults may already be dealing with reduced mobility or other chronic conditions, the physical stress caused by unmanaged IBS flares can exacerbate their overall health status more severely than it might for a younger, healthier person.

Additionally, patients who rely on this specific manufacturer’s product due to insurance formularies or pharmacy inventory limitations are at greater risk. If a patient cannot easily obtain a substitute from a different manufacturer, they may be forced to wait for the recall remedy or contact their healthcare provider for an alternative. During this waiting period, their condition remains untreated. For those with severe IBS, even a short gap in medication can trigger significant discomfort that impacts daily functioning, work attendance, and mental well-being. It is also worth noting that while the recall involves Rx-only medications, which inherently limits access to those with a valid prescription, the confusion of receiving an empty or partially empty bottle can cause unnecessary anxiety for patients who are already managing a chronic, often unpredictable condition.

Parents or caregivers administering this medication to younger family members, though less common for this specific drug profile, should also be vigilant. If a child or dependent is dependent on consistent dosing for symptom management, the uncertainty of whether they have received their full dose can lead to under-treatment. The "how" of the risk here is subtle: it is not that the capsule itself is dangerous, but that the integrity of the supply chain has been compromised. Therefore, the most at-risk individuals are those who cannot quickly pivot to a different treatment plan and who rely on the precise quantity and quality of each filled bottle to maintain their daily stability.

How to tell if you have the recalled item

When a recall is announced, the most important step is verifying that your specific bottle is part of the affected batch. Because this recall involves prescription medication distributed nationwide, it is crucial to look at the physical packaging rather than relying on memory or general product knowledge. The FDA has identified a specific set of details that define the recalled inventory. If your bottle matches all of the following criteria, you should stop using it immediately and contact your pharmacist or healthcare provider.

First, check the label for the brand name. The affected product is distributed by Aurobindo Pharma USA, Inc.. While Aurobindo manufactures many medications, this specific recall only applies to their products sold under their own distribution umbrella in this instance. Next, look closely at the drug name and strength. You are looking for Dicyclomine Hydrochloride Capsules, USP, 10mg. This is a prescription-only medication, so it should not be found on a shelf without a valid prescription, but confirm that the strength is exactly 10mg, as other strengths may not be included in this specific batch recall.

The most critical identifiers are the National Drug Code (NDC) and the Batch Number. These are unique fingerprints for this lot of medication. Look for the NDC 59651-719-99. This code is usually printed clearly on the front or back label of the bottle. Alongside the NDC, you must verify the Batch number, which is listed as DMC125018A. If your bottle has a different batch number, it is likely not part of this specific shortfill issue, but you should still confirm with a professional. Also, check the expiration date. The recalled bottles have an expiration date of 07/2027. While a future expiration date might seem reassuring, in this case, it confirms you have the correct lot that was manufactured and distributed during the specific window identified by the FDA.

Finally, note the packaging size. The recall specifically mentions bottles containing 1,000 capsules. This is an unusual quantity for individual patient use and is typically associated with institutional or bulk distribution settings. If you have a standard 30- or 90-count bottle from this brand, it may not be affected, but verifying the NDC and Batch Number remains your best defense. The manufacturer’s address is listed as 279 Princeton-Hightstown Road, East Windsor, NJ 08520, and the product was made in India. If you purchased this medication recently from a pharmacy across the United States, and it matches these exact details, you possess the recalled item.

What to do — step by step

If you have been prescribed or are currently taking Dicyclomine Hydrochloride Capsules, USP, 10mg from this specific recall lot, your immediate priority is to ensure your safety and prevent any further exposure to the defective product. Because the hazard involves a "shortfill" condition where capsules may be empty, continuing to use these bottles could mean receiving little to no active medication for your condition. While the official FDA recall notice does not explicitly state a specific remedy such as a mandatory return address or a direct refund process in this initial alert, the standard protocol for Class II drug recalls involves stopping use and contacting your healthcare provider immediately.

Please follow these concrete steps to protect your health and handle the situation responsibly:

1. Stop taking the medication immediately. Do not consume any more capsules from the affected bottles. The risk here is not necessarily toxicity, but rather treatment failure. If you rely on Dicyclomine to manage conditions like irritable bowel syndrome or other gastrointestinal spasms, receiving empty capsules means your symptoms may return unchecked. Treat this gap in coverage as a medical urgency.
2. Contact your prescribing physician or pharmacist right away. Call the doctor who prescribed this medication and explain that you hold a batch with NDC 59651-719-99, specifically Batch # DMC125018A, which is subject to an FDA recall. They need to know immediately so they can determine if you require a replacement prescription from a different manufacturer or lot number to maintain continuity of care. Do not wait for your next scheduled appointment.
3. Secure the recalled product safely. Take the 1,000-bottle case (or individual bottles) out of your regular medicine storage and place them in a secure location where they cannot be accidentally accessed by family members, children, or pets. Since these are prescription-only drugs, keeping them contained prevents misuse or accidental ingestion while you sort out the next steps.
4. Monitor for symptoms. Pay close attention to your body. If you experience a return of gastrointestinal issues, pain, or spasms that were previously controlled by this medication, seek medical advice promptly. This is likely due to the lack of active ingredient in the shortfilled capsules, but it is important to rule out other causes and get appropriate care.
5. Contact Aurobindo Pharma USA, Inc. for further instructions. Since a specific return or refund remedy is not detailed in the initial recall alert, you must reach out to the distributor directly to ask how they are handling this Class II recall. They can provide guidance on whether they are offering replacements, refunds, or if you should simply dispose of the product according to local regulations. You can contact them at their East Windsor, NJ facility listed in the official notice.

Remember, while a Class II recall indicates that use of the product may cause temporary or medically reversible health problems, it is still critical to act quickly. Your doctor is your best resource for navigating this interruption in your treatment plan. Stay calm, stay informed, and prioritize your ongoing health management.

Your refund, repair, or replacement options

When a recall notice arrives in your mailbox or appears on your pharmacy’s screen, the immediate question is often, “What do I actually get out of this?” It is completely normal to feel a mix of frustration and uncertainty. You might be worried about losing money, losing time, or simply not having access to your necessary medication while you sort things out. In the case of the Aurobindo Pharma USA Inc recall of Dicyclomine Hydrochloride Capsules, USP, 10mg, the official FDA document does not provide a specific remedy such as a direct refund, a prepaid shipping label for returns, or an automatic replacement shipment from the manufacturer. This absence of stated terms can be confusing, but it does not mean you are without recourse. It simply means that the standard path to resolution depends heavily on your relationship with the entity that dispensed the product to you.

Your primary point of contact for any financial reimbursement or product exchange is almost certainly the pharmacy where you filled your prescription. Pharmacies hold the direct contractual and logistical relationship with the wholesaler and the manufacturer. Because this recall involves a manufacturing defect—a shortfill resulting in empty capsules—the liability typically rests with the supply chain partners who distributed the specific batch. When you contact your pharmacist, they are equipped to initiate a return authorization process with their distribution center. They will verify the National Drug Code (NDC 59651-719-99) and the batch number (DMC125018A) on your bottle against the recall list. Once verified, they can replace the medication with a safe, non-defective unit from a different lot or process a refund to your original method of payment. This is the most practical and immediate solution for most consumers.

If you purchased the product directly from Aurobindo Pharma USA Inc rather than through a retail pharmacy, your options become more administrative. Since the recall facts do not list a dedicated consumer hotline or email address for this specific incident, you would need to reach out to the company via their corporate headquarters at 279 Princeton-Hightstown Road, East Windsor, NJ 08520. Be prepared for a longer process here. Manufacturer-led recalls often involve formal claim forms and proof of purchase requirements that can take weeks to resolve. However, even without a stated remedy in the public notice, companies are generally obligated under FDA guidelines to provide a reasonable path for consumers to return defective goods and recover their costs.

It is important to understand why the remedy is not explicitly detailed in the initial recall announcement. The FDA’s role is to alert the public and regulators to the hazard; they do not manage the financial transactions between companies and customers. The “remedy” is effectively the return of the defective product for credit or replacement, facilitated by the distributor. For Class II recalls, like this one involving potential dosing errors due to empty capsules, the focus is on rapid removal from the market. Therefore, your fastest path to getting your money back or your medication fixed is through the pharmacy that dispensed it. They handle the logistics of the reverse supply chain daily and are accustomed to navigating these exact scenarios without requiring you to deal directly with the manufacturer’s legal or customer service departments.

• Contact your dispensing pharmacist first; they can often replace the item immediately if stock allows.
• If a replacement is not available, request a full refund of the product cost, including any co-pay if applicable.
• Keep your original receipt and the recalled bottle handy for verification purposes during the return process.

What can happen if you ignore it

Staying safe: broader tips

When it comes to pharmaceuticals, the most powerful tool you have is a proactive relationship with your pharmacist and healthcare provider. Medications like Dicyclomine Hydrochloride are typically prescribed to manage irritable bowel syndrome or similar gastrointestinal conditions. Because these drugs affect how your body processes signals in the gut, consistency in dosage is key to managing symptoms effectively. This is exactly why receiving a shortfill or an empty capsule is not just an inconvenience—it can disrupt your treatment plan and lead to unexpected flare-ups of discomfort. To prevent this from happening again, make it a habit to verify the integrity of your medication every time you pick it up at the pharmacy counter. If a bottle feels lighter than usual, looks damaged, or if the capsules rattle strangely, speak up immediately. Pharmacists are trained to spot these anomalies and can replace the product on the spot without requiring you to start the process over from scratch.

Beyond the pharmacy visit, maintaining an organized medication inventory at home is a simple yet highly effective safety practice. Many people store prescriptions in bathroom cabinets or kitchen drawers where humidity and heat can degrade the integrity of the packaging and the pills themselves. Keep your medications in a cool, dry place, away from direct sunlight and moisture. This not only preserves the chemical stability of the drug but also makes it easier to spot any discoloration or physical changes in the capsules before you take them. Consider using a weekly pill organizer for daily doses, but always keep the original prescription bottle handy for reference. The label on that bottle contains critical information, including the National Drug Code (NDC) and lot number, which are essential if you ever need to contact the manufacturer or report an adverse event.

Staying informed about product safety also means keeping your contact information up to date with both your healthcare provider and the FDA. The FDA encourages consumers to sign up for their free email alerts, known as MedWatch. By registering, you will receive notifications about new recalls, safety warnings, and updates on medical devices that directly impact public health. This proactive approach ensures that you are not caught off guard by news of a recall, allowing you to take action quickly if your specific medication is affected. Additionally, never hesitate to report any side effects or quality issues you experience while using prescription drugs. Your feedback helps regulatory agencies identify patterns and protect others from similar hazards. By combining diligent home storage practices with active engagement in the broader safety network, you take control of your health journey and ensure that every capsule you swallow is safe, effective, and exactly what it should be.