What was recalled
The U.S. Food and Drug Administration (FDA) has initiated a Class II recall concerning a specific pharmaceutical product distributed by OurPharma LLC. This action involves fentaNYL Citrate, a potent medication typically used in clinical settings for pain management. The specific items under recall are injection solutions packaged in 100 mL bags containing 0.9% Sodium Chloride (NaCl). Each bag is formulated to deliver a concentration of 1,000 mcg/100 mL, which equates to 10mcg/mL of the active ingredient. It is critical for healthcare providers and patients to identify these exact specifications, as even minor variations in concentration or volume can have significant medical implications.
The product in question bears the brand name OurPharma and is associated with NDC number 73013-1013-01. The recall specifically targets Lot number 101301260605, which carries a Beyond Use Date (BUD) of December 9, 2026. These IV bags were distributed nationwide within the United States, meaning that hospitals, clinics, pharmacies, and other healthcare facilities across all states may have received this inventory. The distribution was managed by OurPharma LLC, located at 2512 S. City Lake in Fayetteville, Arkansas. While the company’s headquarters are in AR, the scope of the recall is not limited to that geographic area due to the national distribution pattern.
The official recall date for this action is September 3, 2026. This timeline indicates that the issue was identified and reported relatively recently, prompting an immediate response from both the manufacturer and regulatory authorities. The decision to classify this as a Class II recall suggests that while the product may cause temporary or medically reversible health problems, it is not expected to result in serious adverse health consequences under normal circumstances. However, given the high-alert nature of fentaNYL, any discrepancy in labeling is treated with utmost seriousness. The primary concern stems from a complaint received on August 31, 2026, which highlighted discrepancies regarding the expiry dates printed on the IV bags versus the actual product expiry date. Specifically, the complaint noted inconsistencies between the bag expiry dates of July 31, 2026, and November 30, 2026, compared to the product expiry of December 9, 2026. This confusion necessitates the recall to prevent any potential administration of medication past its intended safety window or based on incorrect expiration data.
If you are a healthcare professional or a patient who may have been treated with this specific lot, it is vital to verify your records against the details provided above. The combination of the NDC number, lot number, and the specific formulation (10mcg/mL in 100 mL NaCl bags) serves as the definitive identifier for this recall. Please ensure that you check your inventory or medical records immediately to determine if any of these exact units are part of your care history.
The hazard, explained
At first glance, a mismatched date on an IV bag might seem like a minor clerical error or a simple printing mistake. However, in the context of pharmaceutical manufacturing and distribution, labeling discrepancies regarding expiration dates represent a significant safety vulnerability. The core issue here is not that the drug itself has necessarily spoiled, but rather that the critical information required to verify its safety and efficacy has been rendered unreliable. When the expiry date printed on the exterior packaging or bag does not align with the actual Beyond Use Date (BUD) or product expiration recorded in manufacturing logs, it creates a dangerous ambiguity for healthcare providers and patients alike.
Fentanyl Citrate is an extremely potent synthetic opioid analgesic, typically used for pain management. Because of its high potency, even minute variations in dosing can lead to severe consequences, including respiratory depression, coma, or death. The reliability of the expiration date is paramount because it serves as the final line of defense ensuring that the medication has retained its chemical stability and sterility up to the point of administration. If a healthcare professional administers this solution based on an incorrect or conflicting expiry date, they are essentially guessing at the integrity of the product. While fentanyl is generally stable for a defined period, that stability cannot be guaranteed if the labeling fails to accurately reflect the true expiration timeline established by OurPharma LLC during production.
The specific hazard in this recall arises from a complaint received on August 31, 2026, which highlighted a discrepancy between the IV bag’s printed expiry dates (listed as July 31, 2026, and November 30, 2026) and the actual product expiration date of December 9, 2026. This inconsistency creates two potential risks. First, if a provider assumes the earlier date (July 31) is correct, they may discard a perfectly safe and usable medication, leading to waste and supply chain disruptions. Second, and more critically, if a provider assumes the product is valid based on one date while it is actually expired or near-expired according to another, they risk administering a solution that may have degraded. Degraded opioids can lose potency unpredictably or, in rare cases, form harmful byproducts. Furthermore, IV solutions are sterile; once past their verified expiration, the preservative systems may fail, allowing bacterial growth that could lead to serious infections such as sepsis when introduced directly into the bloodstream.
In short, the physical problem is a labeling error that obscures the truth about the product's lifecycle. The harm comes from the potential for clinical decision-making based on false data. In medicine, certainty is safety; ambiguity is risk. This Class II recall indicates that while the probability of serious adverse health consequences may be moderate, the potential for patient injury through misadministration or use of compromised sterile products is real and unacceptable.
Who is most at risk
To understand who is truly at risk in this specific recall, we first need to look closely at what the product actually is and how it is used. This is not a medication you would find sitting on a kitchen shelf or kept in a home medicine cabinet for occasional use. The recalled item is fentanyl citrate injection solution, specifically a 1,000 mcg/100 mL concentration mixed in a 100 mL bag of 0.9% sodium chloride (normal saline). This is a potent, high-strength opioid analgesic designed for clinical settings such as hospitals, surgical centers, and pain management clinics. It is administered intravenously, meaning it goes directly into the bloodstream through an IV line. Because of its extreme potency—fentanyl is significantly stronger than morphine or heroin—the primary users are medical professionals who are trained to calculate precise dosages based on a patient’s weight, age, and medical history. Therefore, the general public, including families with children or elderly relatives managing chronic pain at home, is not directly exposed to this specific batch of product through normal daily life.
The risk here is nuanced and stems from a labeling discrepancy rather than the drug itself being contaminated or dangerous in its intended form. The FDA recall highlights a critical error: the expiration dates printed on the IV bag do not match the actual Beyond-Use Date (BUD) of 12/09/2026. Specifically, there were complaints about mismatches where the bag showed either 07/31/2026 or 11/30/2026, while the product’s true expiration was later in December. In a high-pressure hospital environment, this ambiguity can lead to serious errors. Healthcare providers might discard medication that is still safe to use, leading to supply shortages for patients who need it. Conversely, and more dangerously, staff might inadvertently use the medication past its safe expiration if they rely on the incorrect earlier date printed on the bag, or they might confuse stock during busy shifts. The people most at risk in this scenario are patients currently receiving care in facilities that received Lot #101301260605 from OurPharma LLC.
While any patient could be affected by a dosing error caused by confusing labels, certain groups face higher stakes if an error occurs. Patients with compromised respiratory systems, such as those undergoing major surgery or recovering in intensive care units, are particularly vulnerable to the effects of fentanyl. Fentanyl suppresses the drive to breathe; if a healthcare provider misinterprets the label and administers a dose based on incorrect expiration assumptions, or if the medication’s stability is questioned due to the date confusion, the margin for error shrinks dramatically. Additionally, elderly patients often have slower metabolisms and reduced kidney or liver function, making them more sensitive to opioids. If this recalled lot was distributed to hospitals nationwide and used in these vulnerable populations without proper verification against the correct BUD of 12/09/2026, those individuals are at the center of the safety concern. It is vital for medical facilities to immediately check their inventory against the specific NDC 73013-1013-01 and Lot number provided in the FDA notice to ensure these patients are not inadvertently exposed to the labeling confusion.
How to tell if you have the recalled item
Identifying whether your medication is part of this specific FDA recall requires careful attention to several distinct details printed on the packaging and the IV bag itself. Because fentanyl is a potent opioid, it is critical that you do not rely solely on the brand name or a general description of the drug. Instead, you must verify the exact National Drug Code (NDC), lot number, and Best Use Date (BUD). If any of these details do not match the information below exactly, your item is likely safe from this particular recall, but you should always consult your pharmacist to confirm.
First, look at the outer carton or the label on the IV bag. You are looking for a product manufactured by OurPharma. The specific drug name is fentaNYL Citrate, and the concentration is precisely 1,000 mcg/100 mL (which equals 10mcg/mL). This medication comes as an injection solution contained in a 100 mL bag that includes 0.9% NaCl (normal saline). It is important to note that this recall does not apply to fentanyl products from other manufacturers, different concentrations, or different bag sizes.
The most critical identifiers for verification are the Lot Number and the National Drug Code. You must find a label that displays the NDC 73013-1013-01. Next to this code, look for the Lot Number: 101301260605. If your bag has a different lot number, it is not included in this recall. Additionally, check the Best Use Date (BUD) printed on the packaging. For this specific recalled lot, the BUD is listed as 12/9/2026. While the recall notice mentions discrepancies regarding other dates found on the bag (such as 07/31/2026 and 11/30/2026), the definitive identifier for the recalled product is the combination of the NDC, the lot number above, and the BUD of 12/9/2026.
If you are a patient or a healthcare provider checking inventory, remember that this product was distributed nationwide within the United States. Therefore, knowing where you purchased it may not help narrow down the search, as it could have come from any pharmacy, hospital, or clinic across the country. The manufacturer’s address is listed as 2512 S. City Lake, Fayetteville, AR, but this does not mean only products from Arkansas are affected. Take your time to read every number on the label. When in doubt, contact OurPharma directly using the recall contact information provided in the official FDA notice or speak with your healthcare provider immediately.
What to do — step by step
If you or your healthcare facility are in possession of the recalled fentanyl citrate injection solution distributed by OurPharma LLC, it is critical to act immediately to ensure patient safety. Because this recall involves a high-alert medication where dosage accuracy and sterility are paramount, ignoring the discrepancy in labeling information is not an option. The FDA has classified this as a Class II recall, which indicates that use of the product could cause temporary or medically reversible harm to health. Therefore, the following steps outline how to secure the situation, protect your patients, and comply with regulatory requirements. First, stop using the affected product immediately. If you are a healthcare provider in AR or any other part of the nationwide distribution network, do not administer this specific lot of fentanyl citrate to any patient. Quarantine the remaining units in a secure location within your pharmacy or nursing station to prevent accidental use. Clearly label these bags with "DO NOT USE - RECALLED" to ensure that no staff member inadvertently picks them up for administration. This step is vital because the core issue involves conflicting expiration dates on the IV bag and the product itself, which could lead to the use of a medication past its intended stability period or cause confusion regarding its potency. Second, identify exactly which units are affected by checking the lot number and NDC. You need to verify that you have the specific items listed in the recall notice. Look for NDC 73013-1013-01 and Lot # 101301260605. The product is fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in 100 mL, 0.9% NaCl Bag. If your inventory records do not show this exact lot number or NDC combination, you may not have the recalled product. However, if they do match, proceed to the next step without delay. Third, contact OurPharma LLC directly to report the issue and inquire about the remedy. The official recall announcement does not currently state a specific remedy, such as a prepaid return label or a direct refund process. This means you must reach out to the manufacturer to get clear instructions on how to dispose of or return the product. They will likely provide guidance on whether you should destroy the product under supervision or return it for credit. Keep detailed records of all communications with OurPharma, including dates, times, and the names of representatives you speak with. This documentation is essential for your facility’s compliance audits and for any future claims regarding inventory loss. Fourth, monitor for any adverse events. If any patients have already received this medication before the recall was issued, watch them closely for any unexpected side effects or complications related to dosage inaccuracies due to labeling confusion. Report any such incidents to the FDA MedWatch program. This helps regulatory agencies understand the real-world impact of the labeling discrepancy and ensures that broader safety measures are taken if necessary. By following these steps, you help maintain trust in the supply chain and ensure that no patient is put at risk due to administrative errors in product labeling.Your refund, repair, or replacement options
When a medical product is recalled, the most immediate question for many people is, "What happens to the money I spent?" and "How do I get rid of this safely?" In this specific case involving OurPharma LLC’s fentanyl citrate injection solution, the official FDA recall announcement does not explicitly list a standard consumer remedy such as a direct refund, a store credit, or a free replacement shipment. This absence of stated financial compensation is common in Class II drug recalls, particularly those involving prescription medications distributed through professional healthcare channels rather than retail shelves. It is important to understand that "no stated remedy" does not mean you are left without recourse; it simply means the process is handled differently than a typical product return at a big-box store.
Because this recall involves a potent controlled substance (fentanyl) and stems from a labeling discrepancy regarding expiration dates, the primary focus of the manufacturer’s response is on the safe retrieval and destruction of the product, not necessarily on financial restitution to the end patient. The remedy here is fundamentally about risk mitigation. Your "option" in this scenario is to ensure the recalled units are removed from use immediately. If you are a healthcare provider or pharmacy that received these bags, your obligation is to quarantine the stock and contact OurPharma LLC or the FDA directly for instructions on return or destruction. The company’s address, 2512 S. City Lake in Fayetteville, AR, is the point of origin, but for official coordination, you should refer to the FDA recall notice for specific inbound logistics.
If you are a patient who has already received this medication, the concept of a "refund" is complex. Prescription drugs are generally dispensed as part of a medical service, and the cost is often covered by insurance or paid at the point of care. You do not typically return the physical drug to the pharmacy for a cash refund because it is unsafe to put it back in stock. Instead, your remedy is to ensure that any unused portion is disposed of properly through a drug take-back program or as directed by your healthcare provider. The "value" you retain is the safety guarantee that the discrepancy has been identified and that future doses will be accurately labeled.
For those wondering about contact details, the recall facts provided do not list a specific 1-800 number or email address for customer service. This is not uncommon in FDA Class II recalls where the primary communication channel is through medical regulatory networks rather than direct consumer hotlines. To initiate any potential resolution or to report an issue, you should contact OurPharma LLC directly at their Fayetteville, Arkansas facility or consult the full FDA press release for updated contact information. Always verify any instructions you receive by cross-referencing them with official FDA databases, as recall procedures can evolve as the investigation continues.
- Do not attempt to sell or donate the recalled bags. They must be destroyed according to hazardous waste protocols.
- Contact your pharmacist if you are unsure whether your specific lot is affected. They have access to detailed distribution records.
- Monitor official FDA updates for any later addition of a specific return address or reimbursement protocol, as these can be added after the initial recall announcement.
What can happen if you ignore it
When a medication like fentanyl citrate is involved in a recall due to labeling discrepancies, the consequences of ignoring the warning are not merely administrative; they are potentially life-threatening. In this specific case, OurPharma LLC has recalled fentaNYL Citrate Injection solution because the expiration dates on the IV bag and the product itself do not match correctly. While the immediate error is a matter of documentation and tracking, the underlying risk stems from the nature of the drug and the confusion such labeling errors create in high-stakes medical environments. Fentanyl is an extremely potent synthetic opioid analgesic, typically used for pain management, often in surgical or critical care settings. It is measured in micrograms (mcg), meaning even a tiny deviation in dosage can have profound physiological effects. If healthcare providers or patients continue to use this product despite the recall notice, they are operating without reliable information regarding the drug’s stability and potency. Expiration dates are not arbitrary; they represent the point up to which the manufacturer guarantees the full strength and safety of the medication under specific storage conditions. When labels show conflicting dates—such as an IV bag expiry of July 31, 2026, November 30, 2026, and a product expiry of December 9, 2026—it creates a dangerous ambiguity. A medical professional might inadvertently use a bag that is past its safe limit for intravenous administration, or they might assume the drug is stable when it is not. For a drug as narrow-therapeutic-as fentanyl, stability issues can lead to degradation products that may be ineffective or, in worse cases, toxic. The real-world consequence of ignoring this recall is the potential for medication error. In a hospital setting, confusion over expiration dates can delay treatment, cause unnecessary panic, or lead to the administration of compromised medication. If the drug has degraded, it might not provide adequate pain relief during a critical procedure, leaving a patient in distress. Conversely, if degradation alters the chemical structure in unexpected ways, it could trigger an adverse reaction. While the recall facts do not currently report any specific injuries or incidents resulting from this labeling error, the risk is inherent in the product class. Fentanyl overdose can lead to respiratory depression, coma, and death. Any factor that introduces uncertainty into its administration increases the margin for error. Furthermore, ignoring a Class II recall undermines the safety net designed to protect patients. The FDA classifies recalls based on the severity of the hazard. A Class II classification indicates that use of or exposure to the violative product may cause temporary or medically reversible serious health consequences, or where the probability of serious adverse health consequences is remote. By continuing to use this product, you are bypassing a critical safety check. You might assume that because the drug looks normal and smells normal, it is safe. However, chemical stability cannot be assessed by sight alone. The only way to ensure your safety is to stop using the product immediately and follow the remedy instructions provided by the manufacturer or your healthcare provider.Staying safe: broader tips
When you are dealing with sensitive medical products like prescription injectables, the margin for error is incredibly small. While this specific recall highlights a labeling discrepancy, it serves as a powerful reminder that vigilance is your best defense against medication errors. One of the most effective ways to stay safe is to adopt a "pause and verify" habit before any administration. Never assume that the information on the immediate container matches the master record or the patient's chart without a visual confirmation. In clinical settings, this means taking an extra ten seconds to read the expiration date printed directly on the bag, rather than relying solely on secondary labels that may have been applied incorrectly or become damaged. For home care patients, keep your medications in their original packaging until the moment of use and store them in a cool, dry place away from direct sunlight, which can degrade both the drug and the ink on the label.
Regularly checking for official government recalls is another critical layer of protection. Many people do not realize that the FDA and other agencies issue thousands of alerts each year. You should subscribe to email notifications from the FDA’s Recalls page or download their mobile app if available. This proactive approach ensures you are not waiting for a news report to find out that a product you might be using is unsafe. It is also wise to keep a simple log of your medications, including lot numbers and expiration dates, especially for high-alert drugs like fentanyl or other potent opioids. If you ever receive a notification about a lot number that matches your supply, stop using the item immediately.
Furthermore, communication within healthcare teams is vital for preventing labeling errors. Nurses, pharmacists, and doctors should establish a culture where questioning a discrepancy is encouraged, not discouraged. If a label looks odd, if dates seem inconsistent, or if the packaging feels different than usual, speak up. It is always better to waste a moment verifying a doubt than to risk a patient's safety. Finally, ensure that all medical supplies are stored securely and out of reach of children or pets, even when they appear to be properly labeled. Proper disposal of unused or expired medications through take-back programs also helps prevent accidental ingestion or misuse by others in the household.