Over 580,000 Bottles of Prazosin Hydrochloride Recalled Over Cancer Risk
The U.S. Food and Drug Administration (FDA) has raised significant concerns across the healthcare community. More than 580,000 bottles of a commonly prescribed high blood pressure medicine, prazosin hydrochloride, have been recalled across the United States after the discovery of potentially cancer-causing chemical impurities. The recall, announced on October 31, 2025, was initiated voluntarily by Teva Pharmaceuticals USA, a major New Jersey–based drug manufacturer, along with Amerisource Health Services, which distributes the medicine nationwide. The FDA has classified this recall as a Class II risk, meaning the chances of serious adverse health consequences are considered remote, but the medication may still pose temporary or medically reversible health risks if consumed.
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Prazosin hydrochloride is a well-known medication used primarily for the treatment of high blood pressure, or hypertension. It works by relaxing the muscles in blood vessel walls, allowing blood to flow more easily and thereby lowering blood pressure. In addition to its cardiovascular benefits, prazosin is also prescribed for certain mental health conditions, particularly post-traumatic stress disorder (PTSD). Many patients with PTSD experience recurring nightmares or severe sleep disturbances, and prazosin has been proven effective in reducing the intensity and frequency of such symptoms. Because it is used for both cardiovascular and psychiatric purposes, the medication is widely distributed across the country, making this recall a matter of considerable public interest.
| Category | Detail |
| Recalled Product | Prazosin Hydrochloride Capsules (1 mg, 2 mg, and 5 mg strengths) |
| Manufacturer | Teva Pharmaceuticals USA (distributed by Amerisource Health Services) |
| Reason for Recall | Presence of N-nitroso Prazosin impurity C (a type of nitrosamine) |
| FDA Classification | Class II Risk |
| Scale of Recall | 580,844 bottles removed from the market |
Medication Use
Prazosin hydrochloride is widely prescribed for two primary conditions:
Hypertension (High Blood Pressure): It relaxes blood vessel wall muscles, aiding blood flow and lowering blood pressure.
Post-Traumatic Stress Disorder (PTSD): It is effective in reducing the intensity and frequency of severe nightmares and sleep disturbances associated with PTSD.
According to the FDA’s official recall notice, the reason behind the recall lies in the detection of nitrosamine impurities, specifically N-nitroso Prazosin impurity C. Nitrosamines are a class of chemical compounds that have been identified as potentially carcinogenic meaning they may increase the risk of developing cancer after prolonged exposure. These impurities can form unintentionally during the drug manufacturing process or while the medication is stored, particularly if certain chemical reactions occur between ingredients or if environmental conditions such as heat, humidity, or contamination are not properly controlled. Although nitrosamines can be present in trace amounts in food, water, and the environment, exposure to higher levels over time has been linked to cancers affecting the liver, bladder, and stomach.
In its public communication, the FDA explained that the recall was initiated out of caution and emphasized that the likelihood of immediate or severe harm is low. The Class II recall designation reflects this assessment. Under FDA classification standards, a Class II recall is used for situations in which the use of, or exposure to, a product may cause temporary or medically reversible health effects, or in which the probability of serious adverse health consequences is remote. Nevertheless, because hypertension and PTSD are chronic conditions requiring long-term medication, even low-level exposure to potential carcinogens can pose meaningful risks over years of continuous use.
The scale of this recall is significant. In total, 580,844 bottles of prazosin hydrochloride capsules are being removed from the market. This includes 181,659 bottles of the 1 mg strength, 291,512 bottles of the 2 mg strength, and 107,673 bottles of the 5 mg strength. Each bottle may contain up to 1,000 capsules. These products were distributed across the United States, and while no serious adverse events have yet been reported, the recall aims to prevent potential long-term health consequences. Teva Pharmaceuticals and Amerisource Health Services have confirmed that the recall is voluntary and precautionary, demonstrating a commitment to product safety and regulatory compliance.
Teva Pharmaceuticals, one of the world’s largest generic drug manufacturers, has faced similar challenges in the past along with other companies in the pharmaceutical industry. In recent years, several blood pressure medications, including valsartan, losartan, and irbesartan, were recalled for the same reason the presence of nitrosamine impurities. These incidents have prompted the FDA and manufacturers to enhance their surveillance and testing standards. Despite these efforts, the recurring nature of such recalls reveals the persistent difficulty in completely eliminating the formation of nitrosamines during production.
For patients, this recall understandably raises concerns. Many people who rely on prazosin hydrochloride may feel anxious about whether their specific medication is affected. The FDA and healthcare professionals are advising patients not to stop taking the medication abruptly without consulting a healthcare provider. Suddenly discontinuing blood pressure medication can cause a dangerous spike in blood pressure, leading to complications such as stroke or heart attack. Instead, patients are encouraged to check the label of their medication bottle to identify the manufacturer and lot number. This information can be cross-referenced with the official FDA recall list, available on the agency’s website. If their product is part of the recalled batch, they should contact their pharmacist or doctor to discuss alternatives or replacements.
Nitrosamine contamination has been a recurring issue in the pharmaceutical sector globally, and regulatory agencies are still working to determine exactly how these impurities form and how best to prevent them. Nitrosamines can be produced when certain drug ingredients react with one another or with materials used in the manufacturing process. Factors such as solvent choice, reaction temperature, and even packaging materials can influence the likelihood of formation. The FDA and other international health authorities, including the European Medicines Agency (EMA), have issued strict guidelines requiring drug manufacturers to identify potential sources of nitrosamine formation and implement preventive measures. Despite these safeguards, the complexity of chemical synthesis and the sensitivity of some compounds make absolute prevention difficult.
According to the FDA’s official statement, “Use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.” The agency reiterated that the recall was voluntary and that Teva Pharmaceuticals is cooperating fully with authorities to remove affected products from circulation. The FDA has also stressed that it continues to monitor the market for any similar contamination risks and that patients should report any adverse events related to the use of recalled medicines through the FDA’s MedWatch program.
From a public health perspective, the recall underscores the importance of pharmaceutical vigilance and post-market surveillance. Even though modern drug manufacturing follows rigorous safety protocols, contaminants can still arise due to complex chemical reactions, raw material impurities, or environmental factors. Recalls such as this demonstrate both the challenges and the strengths of the system the challenge of ensuring perfect chemical purity in large-scale drug production, and the strength of regulatory oversight that swiftly identifies and removes potentially harmful products from the market.
Healthcare experts emphasize that the risk of cancer or other health complications from short-term use of contaminated prazosin is extremely low. However, patients who have taken the drug for an extended period, especially those who consume it daily for years, should discuss their concerns with a healthcare professional. A doctor can help determine whether any additional health monitoring or changes in treatment are necessary.
The recall of over 580,000 bottles of prazosin hydrochloride represents one of the larger precautionary actions of 2025 in the category of hypertension medications. It is a reminder that even with today’s advanced manufacturing and testing systems, pharmaceutical safety remains an evolving process. The FDA continues to enhance its regulatory standards, requiring companies to test for a broader range of impurities and to report any potential contamination immediately.
Advice for Patients
The FDA and healthcare professionals have issued critical advice for patients currently taking prazosin hydrochloride:
Do Not Stop Abruptly: Patients are strongly advised not to suddenly discontinue the medication without consulting a healthcare provider. Abrupt cessation of blood pressure medication can cause a dangerous spike in blood pressure, potentially leading to a stroke or heart attack.
Check Your Medication: Patients should check the label on their bottle for the manufacturer and lot number. This information should be compared against the official FDA recall list, which is available on the agency's website.
Consult a Professional: If your product is part of the recalled batch, contact your pharmacist or doctor immediately to discuss alternative medications or a replacement supply.