What was recalled
The U.S. Food and Drug Administration has issued a recall involving specific batches of Cyanocobalamin injection USP manufactured by American Regent, Inc. This medication is widely recognized as Vitamin B12, a supplement commonly prescribed to treat deficiencies that can lead to fatigue, weakness, and neurological issues. The particular products affected by this recall are packaged for intramuscular (IM) or subcutaneous (SC) use only, meaning they are intended to be injected directly into muscle tissue or under the skin, rather than taken orally or administered through a vein. American Regent, Inc., based in Shirley, New York, is the company responsible for this distribution and subsequent recall action.
The recall specifically targets two distinct packaging configurations of the same drug concentration. The first configuration consists of individual 10 mL multi-dose vials containing Cyanocobalamin injection at a strength of 10,000 mcg/10 mL, which equates to 1,000 mcg per milliliter. These individual vials are identified by the National Drug Code (NDC) number 0517-0032-01. The second configuration involves bulk packaging, specifically cases containing twenty-five of these same 10 mL multi-dose vials. This larger case pack is identified by the NDC number 0517-0032-25. Both packaging types are classified as prescription-only (Rx Only) medications, indicating that they should only be dispensed following a valid prescription from a healthcare provider.
A critical detail in identifying the affected products is the lot number and expiration date. The recall applies exclusively to the product with Lot Number 25082, which has an expiration date of March 31, 2027. It is important to note that this recall was initiated on July 24, 2026. Healthcare providers, pharmacies, and patients should verify any Cyanocobalamin injection they possess against these specific lot and NDC numbers to determine if the item is part of this recall. The products were distributed nationwide within the United States, meaning that patients in any state could potentially have been prescribed or filled a prescription containing these affected vials. This is classified as a Class II recall by the FDA, which indicates that use of or exposure to the defective product may cause temporary health problems or pose only a slight threat of a serious nature.
- Product Name: Cyanocobalamin injection USP, 10,000 mcg/10 mL (1,000 mcg/mL)
- Manufacturer: American Regent, Inc., Shirley, NY 11967
- NDC Numbers: 0517-0032-01 (single 10 mL vial) and 0517-0032-25 (case of 25 x 10 mL vials)
- Affected Lot Number: 25082
- Expiration Date: 3/31/2027
- Recall Date: 2026-07-24
- Distribution: Nationwide within the U.S.
The hazard, explained
When you receive a prescription of Cyanocobalamin injection USP from American Regent, Inc., the expectation is that the liquid inside the vial is sterile, clear, and chemically stable. This medication is designed for intramuscular (IM) or subcutaneous (SC) use, meaning it is intended to be injected directly into muscle tissue or the layer of fat just beneath the skin. The integrity of this delivery system relies entirely on the purity of the fluid. In this specific recall, that integrity has been compromised by the presence of particulate matter—tiny solid particles that should not exist in an injectable solution. According to FDA records, these contaminants have been identified as hair, glass fragments, and/or paraformaldehyde. Understanding why this is dangerous requires looking at what happens when foreign objects enter a closed system like a vial.
The primary physical danger lies in the size and nature of these particles. Injectables are manufactured to be "pyrogen-free" and particulate-free because the human body has limited ways to handle solid matter introduced directly into the bloodstream or deep tissue. If the vial contains glass shards, even microscopic ones, they remain sharp and rigid. When injected, these fragments do not dissolve. Instead, they can cause immediate mechanical trauma to the capillaries and tissues at the injection site. This is not merely a question of irritation; it is a physical injury caused by foreign bodies penetrating tissue layers that are designed to be smooth and unobstructed. The presence of hair further complicates this, as organic material like hair carries a high risk of harboring bacteria or fungi, turning a simple contamination into a potential source of infection.
Beyond the immediate physical trauma, the chemical nature of some of these contaminants poses a different kind of threat. Paraformaldehyde is a polymer of formaldehyde, a known irritant and toxic substance. While formaldehyde is sometimes used in trace amounts during manufacturing processes to stabilize certain compounds, it must be completely removed or neutralized before the final product reaches the patient. If paraformaldehyde remains in the final solution, it can cause severe local tissue reactions. Upon injection, this chemical contaminant can trigger intense inflammation, necrosis (tissue death), and potentially systemic allergic responses. The body recognizes these particles as invaders, launching an immune attack that results in pain, swelling, and redness far beyond what is typical for a standard vitamin B12 shot.
The risk escalates significantly depending on where the injection is administered. Because this product is labeled for IM or SC use, the particles are deposited deep into the tissue matrix. The body’s natural filtration systems in the skin cannot easily remove large particulates once they are pushed past the epidermis. If these particles enter a blood vessel during injection—a risk that increases if the needle hits a small vein—they can travel through the circulation. While glass and hair are generally too large to cause widespread embolisms in most cases, their presence indicates a profound failure in quality control. It suggests that the manufacturing environment was not adequately controlled, raising concerns about other unseen contaminants that may also be present but undetected. This is why the FDA classifies this as a Class II recall: while it is unlikely to cause serious adverse health consequences for every user, the potential for injury is real and requires immediate attention.
Furthermore, the multi-dose nature of these vials amplifies the hazard. If you have already used part of the vial, the remaining liquid may still contain suspended particles that have settled or drifted within the container. Unlike a single-use syringe that is discarded after one injection, a multi-dose vial is accessed repeatedly. Each time the needle pierces the rubber stopper, there is a risk of introducing new contaminants or disturbing settled particulates, making the remaining contents unpredictable and unsafe for any subsequent use. The uncertainty of whether a specific dose contains a visible shard of glass or a microscopic fiber makes it impossible to guarantee safety without discarding the entire batch.
Who is most at risk
To understand who is truly at risk in this specific recall, we first need to look closely at what Cyanocobalamin actually is and how it is administered. This product is not a topical cream or an over-the-counter vitamin you might take with a glass of water on your morning commute. It is a prescription-only injection designed for intramuscular (IM) or subcutaneous (SC) use. This distinction is critical because the route of delivery bypasses the body’s natural filtration systems, such as the digestive tract and the liver, placing any contaminant directly into the bloodstream or deep tissue layers. Therefore, the primary group at risk consists of patients who have been prescribed this specific medication by a healthcare provider to treat vitamin B12 deficiency, anemia, or other related conditions that require direct injection therapy.
The individuals most vulnerable to the consequences of particulate matter in an injection are those receiving long-term care, particularly the elderly and those with compromised immune systems. Cyanocobalamin injections are often part of a recurring treatment plan for older adults who may struggle with absorbing B12 orally due to age-related changes in digestion. Because these patients rely on these shots for ongoing health maintenance, they are more likely to encounter multiple vials over time. If the contamination described—hair, glass, and paraformaldehyde—is present in the lot numbered 25082 expiring on March 31, 2027, any patient receiving this treatment during this window is exposed. The elderly population is particularly susceptible because their vascular systems may be more fragile, making them less able to handle the physical blockage caused by foreign particles like glass shards or hair fibers.
Furthermore, we must consider the nature of the contaminants themselves when assessing risk. The presence of glass and hair suggests a mechanical failure in the manufacturing process, which poses an immediate physical danger. Glass particles can cause embolisms if they enter smaller blood vessels, leading to tissue damage or blockages in critical organs. Hair can introduce bacteria or cause inflammatory reactions at the injection site. For patients with diabetes or peripheral vascular disease, who already have reduced circulation and slower healing capabilities, these complications can escalate from minor irritation to serious infection or necrosis much faster than in a healthy individual.
Additionally, the mention of paraformaldehyde introduces a chemical hazard that goes beyond physical trauma. Paraformaldehyde is a polymer of formaldehyde, which is known to be irritating and potentially toxic if it enters tissues directly. While the body can process small amounts of formaldehyde naturally, introducing it via injection circumvents normal detoxification pathways. This poses a unique risk to anyone with respiratory sensitivities or chemical allergies, as well as pregnant women who must consider potential systemic effects on fetal development. Although the FDA has not yet reported specific incidents of harm in this recall, the potential for adverse reactions is significant because the hazard is both physical and chemical, affecting a wide range of patients regardless of their baseline health status.
- Patients with B12 Deficiency: Those actively using this medication for medical treatment are the primary group at risk due to direct exposure.
- Elderly Individuals: Older adults often require repeated injections and may have more fragile blood vessels, increasing the risk of embolisms from glass particles.
- Immunocompromised Patients: Individuals with weakened immune systems are at higher risk for infections stemming from hair-borne contaminants or inflammatory responses to foreign materials.
- Pregnant Women: Chemical contaminants like paraformaldehyde pose potential risks to fetal development that do not apply to the general population.
How to tell if you have the recalled item
If you are a healthcare provider, pharmacist, or someone who manages medical supplies for home use, taking a few minutes to physically inspect your inventory is the most important step you can take right now. This recall involves a very specific formulation of Cyanocobalamin injection USP, and because these medications look similar to other B12 products on the market, careful attention to detail is essential. You need to verify not just the drug name, but the exact concentration, packaging type, manufacturer details, and most critically, the lot number. Here is a practical guide to identifying whether the product in your possession is part of this specific recall.
First, locate the vial and examine the label closely. You are looking for a product manufactured by American Regent, Inc., located in Shirley, New York (zip code 11967). The drug itself is Cyanocobalamin injection USP with a strength of 10,000 mcg/10 mL (which is equivalent to 1,000 mcg/mL). It is crucial to note that this product is intended for Intramuscular (IM) or Subcutaneous (SC) use only. If the label indicates any other route of administration, it is not part of this recall.
Next, check the National Drug Code (NDC) printed on the box and the vial. This recall affects two specific packaging configurations under NDC 0517-0032. You must verify if you have either of the following:
- NDC 0517-0032-01: A single 10 mL Multi-Dose Vial.
- NDC 0517-0032-25: A carton containing 25 individual 10 mL Multi-Dose Vials.
The most definitive way to confirm if your item is affected is by checking the Lot Number. The recall applies exclusively to lots manufactured under Lot #25082. If you have a different lot number, this specific contamination issue does not apply to your vial. Additionally, check the expiration date on the label. The recalled product has an expiration date of March 31, 2027. While the expiration date alone doesn’t confirm the recall, it helps narrow down the batch if the lot number is partially obscured or difficult to read.
Finally, remember that this distribution pattern was nationwide within the United States. If you purchased these items from a major pharmacy chain, hospital supplier, or medical distributor across any state between July 2024 and the recall date of July 24, 2026, there is a possibility they are included. However, do not guess. If the NDC matches, the manufacturer is American Regent, and the Lot Number is 25082, you must treat the product as recalled regardless of where or when it was bought. Do not use or administer these injections until you have confirmed they are not part of this lot.
What to do — step by step
When you receive news of a drug recall, especially one involving foreign material like hair or glass, it is natural to feel unsettled. However, the most important thing you can do right now is remain calm and act methodically. Because the official FDA recall notice for this specific American Regent, Inc. Cyanocobalamin injection does not explicitly state a detailed remedy protocol in the provided text, we must rely on standard safety procedures for Class II drug recalls involving particulate contamination. Your primary goal is to prevent any further exposure to the contaminated product while you determine your next steps.
First and foremost, stop using this medication immediately. If you have vials of Cyanocobalamin injection USP, 10,000 mcg/10 mL (1,000 mcg/mL) for IM or SC use only, do not administer any more doses, even if the liquid appears clear to the naked eye. The presence of particulate matter such as glass shards or paraformaldehyde can cause serious tissue damage, embolisms, or other adverse reactions that are not visible without microscopic analysis. It is crucial to understand that "Class II" indicates a situation where use of the product might cause temporary or medically reversible health consequences, but ignoring the recall removes your ability to prevent those outcomes.
Next, identify exactly which vials you have by checking the lot number and expiration date printed on the packaging. You are looking specifically for Lot # 25082 with an expiration date of March 31, 2027. This recall affects two specific package configurations: the single 10 mL Multi-Dose Vial with NDC 0517-0032-01 and the case of 25x10 mL Multi-Dose Vials with NDC 0517-0032-25. If you are a patient, check your home medication cabinet or contact your pharmacy to see if they have records of this specific lot. If you are a healthcare provider, conduct an immediate inventory audit of your stock.
Once you have confirmed possession of the recalled lots, do not attempt to dispose of them in household trash, as this poses risks to sanitation workers and the environment. Instead, contact your pharmacist or healthcare provider right away. They will guide you on how to safely return or dispose of the product according to local regulatory guidelines. In many cases, pharmacies have established take-back programs for contaminated pharmaceuticals. If you are a distributor or wholesaler, follow the specific instructions provided by American Regent, Inc., who may arrange for the retrieval of the product from your facility.
Finally, monitor your health closely if you have used this product prior to discovering the recall. While the recall notice does not list specific reported incidents, particulate matter in injections carries inherent risks. If you experience any unusual symptoms at the injection site or otherwise after using a dose from Lot # 25082, seek medical attention promptly and inform your provider that you may have been exposed to recalled Cyanocobalamin. They can assess whether any intervention is needed. Remember, the absence of stated remedy details in the initial alert means you must proactively reach out to the supply chain to ensure you are not left without guidance.
Your refund, repair, or replacement options
In the immediate aftermath of a product recall, particularly one involving a pharmaceutical compound like Cyanocobalamin injection USP, the most pressing concern is often the practical matter of what happens to the medication in your possession. It is completely natural to feel uncertain about the next steps, but it is important to approach this situation with clarity and calm. The primary goal of any recall remedy is to remove the hazardous product from the supply chain and ensure that no one continues to use a potentially contaminated item. In this specific instance involving American Regent, Inc., the official FDA recall documentation does not currently list a specific, detailed remedy such as a direct refund process, a repair service, or an automatic replacement program for consumers.
This absence of a stated consumer-facing remedy might initially seem confusing, but it is actually quite common in Class II drug recalls, especially those involving manufacturing defects like the presence of particulate matter. The "remedy" in these cases is primarily defined by the act of withdrawal and return to the manufacturer or distributor. American Regent, Inc., located in Shirley, New York, has initiated this recall nationwide. While the official record does not provide a dedicated customer service hotline or a web portal for refunds, the standard procedure for healthcare providers and patients is to cease use immediately and contact the point of purchase or the manufacturer directly to arrange for the return of the product.
If you are a patient who has been prescribed this specific lot (Lot # 25082) or holds inventory of NDC 0517-0032-01 or NDC 0517-0032-25, do not attempt to dispose of the medication in your household trash. Instead, reach out to the pharmacy or medical facility where you obtained the Cyanocobalamin injection. They are equipped to handle the logistics of returning Class II recalled drugs under FDA guidelines. For healthcare professionals managing inventory, American Regent has issued a notification requiring the immediate quarantine and return of all affected units. The company is responsible for overseeing the destruction or remediation of these vials, ensuring that the hair, glass, or paraformaldehyde contaminants do not re-enter the market.
Regarding financial reimbursement, the recall notice does not explicitly outline a refund policy for end-users. However, in practice, pharmacies and hospitals typically absorb the cost of recalled inventory as part of their regulatory compliance obligations, meaning patients are generally not out of pocket for the defective product itself. If you have already used any amount of this medication, please consult your healthcare provider immediately to discuss any necessary follow-up care. While the risk from particulate matter varies depending on the nature and size of the contaminant, professional medical advice is essential for personal health decisions. For specific questions about the return process or further clarification on the recall scope, you may need to contact American Regent, Inc., directly, as general consumer contacts are not detailed in this specific FDA filing.
What can happen if you ignore it
When a medication is recalled due to contamination with particulate matter—specifically hair, glass, or paraformaldehyde in this instance—the risks are not merely theoretical. They are immediate, physical, and potentially severe. Cyanocobalamin (Vitamin B12) is typically administered via intramuscular (IM) or subcutaneous (SC) injection. While these routes bypass the digestive system to deliver nutrients directly into the body’s tissues, they also deposit whatever substances are in the vial directly into your bloodstream or surrounding tissue. If you continue to use a vial contaminated with foreign particles, you are introducing non-biological, potentially toxic materials directly into your circulation.
The presence of glass shards is particularly dangerous because glass is rigid and sharp. Once injected, these microscopic fragments can travel through the blood vessels. In smaller capillaries, they may cause micro-emboli, blocking blood flow to tiny areas of tissue. If larger particles enter major veins or arteries, they can travel to critical organs such as the lungs (causing pulmonary embolism), the heart (leading to cardiac issues), or the brain (resulting in stroke-like symptoms). Even if the glass particles are small enough to pass through initial filters in the body, their sharp edges can damage the delicate lining of blood vessels, leading to inflammation, clotting disorders, or internal bleeding that may not be immediately apparent.
Hair and other organic particulates introduce a different set of risks. These materials are not sterile in the same way pharmaceutical-grade substances should be. Introducing foreign organic matter into muscle tissue or the bloodstream can trigger significant immune responses. Your body may react with severe inflammation, abscess formation at the injection site, or systemic allergic reactions ranging from mild rashes to anaphylaxis. Furthermore, hair and other debris can serve as a nidus for bacterial growth, increasing the risk of serious infections such as sepsis, which is a life-threatening response to infection that spreads through the bloodstream.
The third contaminant mentioned, paraformaldehyde, is a chemical compound that releases formaldehyde. Formaldehyde is known to be toxic and irritating to tissues. Injecting it can cause local tissue necrosis (death of cells) at the injection site, leading to severe pain, swelling, and potential long-term damage to the muscle or nerve endings in that area. Systemic absorption could lead to broader toxic effects, including respiratory irritation, kidney stress, or neurological symptoms depending on the dosage and individual sensitivity.
It is crucial to understand that you cannot see these contaminants with the naked eye in most cases. The particles may be microscopic, dispersed evenly throughout the liquid, or settled at the bottom of the vial where they are easily drawn into the syringe if the vial is shaken or tilted. Ignoring the recall assumes that the product is safe because it looks clear, but clarity does not guarantee purity. By continuing to use this medication, you are gambling with your vascular integrity, immune system response, and tissue health for a vitamin supplement that can be replaced by a different, verified manufacturer without risk. The consequences of ignoring this warning are not just about getting sick; they are about introducing foreign, potentially lethal materials into the most critical systems of your body.