The U.S. Food and Drug Administration (FDA) has issued a significant recall of over half a million bottles of blood pressure medication due to concerns about a cancer-causing chemical. This latest development has raised alarms among patients, healthcare providers, and pharmaceutical companies alike.
The recalled medication is prazosin hydrochloride, a drug commonly used to treat high blood pressure and sometimes prescribed off-label for symptoms of post-traumatic stress disorder (PTSD), such as nightmares and sleep disturbances. The issue stems from the presence of a potentially harmful impurity known as “N-nitroso Prazosin impurity C,” which has been found in higher-than-acceptable levels in certain batches of the drug.
This recall, initiated by Teva Pharmaceuticals USA, one of the largest generic drug manufacturers in the United States, affects more than 580,000 bottles of prazosin hydrochloride capsules. These include various strengths—1 mg, 2 mg, and 5 mg—with each bottle containing between 100 to 1,000 capsules.
Understanding the Recall
The FDA has classified this recall as a Class II risk, which means that while the use of the product may lead to temporary or medically reversible adverse health consequences, the probability of serious harm is considered remote. However, the presence of nitrosamine impurities, which are known to be potentially carcinogenic, has prompted the agency to act swiftly.
Nitrosamines are a class of chemicals that can form during the manufacturing or storage of certain drugs. While they are not inherently dangerous at low levels, prolonged exposure or high concentrations can increase the risk of cancer. In this case, the levels of N-nitroso Prazosin impurity C found in the recalled medication exceeded the FDA’s safety thresholds.
Teva Pharmaceuticals USA, based in Parsippany, New Jersey, issued the voluntary recall on October 7, 2025, with the FDA officially classifying it as a Class II risk on October 24, 2025. The company stated that it has not received any complaints related to the affected lots of the drug.
What Patients Should Do
For individuals who have been prescribed prazosin hydrochloride, it is crucial to check the lot numbers of their medication and determine whether it is part of the recall. The FDA provides detailed information on the affected lots through its Enforcement Report, which can be accessed online.
Healthcare providers and pharmacists play a key role in guiding patients through this process. If you believe your medication is part of the recall, the following steps should be taken:
- Check the lot number: Verify if your medication is included in the recall.
- Contact your pharmacist: They can help confirm whether the medication you have is affected and provide guidance on next steps.
- Consult your prescriber: Your doctor can recommend alternative treatments if necessary.
- Dispose of the medication safely: Follow local guidelines for the proper disposal of expired or recalled medications.
GoodRx, a popular prescription price comparison service, advises that patients affected by the recall should not stop taking their medication without consulting a healthcare professional. Instead, they should seek alternatives and ensure that any recalled medication is disposed of properly.
Why Is This Recall Important?
Prazosin hydrochloride is an alpha-blocker that works by relaxing blood vessels, thereby improving blood flow and reducing blood pressure. It is also used off-label for PTSD-related sleep issues, making it an important treatment for many patients. However, the discovery of a potentially harmful impurity in the drug raises concerns about patient safety.
While the FDA has not issued specific guidance on what to do with the recalled medication, the agency emphasizes that the risk of serious harm is low. Nonetheless, the recall underscores the importance of ongoing monitoring and quality control in pharmaceutical manufacturing.
The fact that the recall was initiated voluntarily by Teva Pharmaceuticals highlights the company’s commitment to patient safety. However, it also raises questions about how such impurities could have entered the supply chain in the first place.
The Broader Implications
This recall is part of a growing trend of drug recalls due to contamination with nitrosamines. In recent years, several other medications, including some popular heartburn and diabetes drugs, have been recalled for similar reasons. The FDA has been working closely with manufacturers to identify and address these issues, but the complexity of global supply chains makes it challenging to prevent all instances of contamination.
The recall of prazosin hydrochloride serves as a reminder that even well-established medications can pose risks if not manufactured under strict quality controls. It also highlights the need for continued vigilance from both regulatory agencies and the public.
What Are the Alternatives?
For patients who were taking prazosin hydrochloride for hypertension or PTSD-related sleep issues, there are several alternative treatments available. These include:
- Other alpha-blockers: Such as doxazosin and terazosin, which are also used to treat high blood pressure.
- Beta-blockers: Medications like metoprolol and propranolol can help manage blood pressure and reduce anxiety symptoms.
- Sleep aids: For patients using prazosin for sleep disturbances, non-pharmacological approaches such as cognitive behavioral therapy for insomnia (CBTI) may be beneficial.
- Alternative therapies: Some patients may find relief through lifestyle changes, such as improved sleep hygiene, stress management techniques, and regular exercise.
Healthcare providers will work with patients to determine the most appropriate alternative based on their individual needs and medical history.
How Can Patients Stay Informed?
Staying informed about drug recalls is essential for ensuring personal safety. Here are a few ways to stay updated:
- Visit the FDA website: The FDA regularly updates its Enforcement Report with details about ongoing recalls.
- Sign up for alerts: Many pharmacies and healthcare providers offer email or text alerts when medications are recalled.
- Follow reputable news sources: Trusted outlets like USA TODAY, The Associated Press, and Healthline often report on major drug recalls.
- Talk to your pharmacist: Pharmacists are trained to identify potential issues with medications and can provide valuable guidance.
By staying informed, patients can take proactive steps to protect their health and make informed decisions about their treatment.
Final Thoughts
The recall of prazosin hydrochloride is a significant event in the world of pharmaceuticals, highlighting the importance of quality control and patient safety. While the risk of serious harm is considered low, the presence of a potentially cancer-causing chemical in a widely used medication underscores the need for continuous oversight and transparency.
Patients who have been affected by the recall should take the necessary steps to verify whether their medication is part of the recall and consult with their healthcare providers for guidance. As always, staying informed and proactive is the best way to navigate these types of situations.
Author: Natalie Neysa Alund
Title/Role: Senior Reporter, USA TODAY
Credentials: With over a decade of experience covering health and science news, Natalie has reported on major pharmaceutical developments and public health initiatives across the United States. Her work has been featured in leading national publications and has influenced policy discussions on drug safety and regulation.
Profile Link: USA TODAY Profile
Sources:
– FDA Enforcement Report
– GoodRx Guide to Drug Recalls
– Teva Pharmaceuticals Statement
Related Articles:
– What You Need to Know About Nitrosamine Contamination in Medications
– How to Check if Your Medication Is Recalled
– Alternatives to Prazosin for High Blood Pressure
Call to Action:
Stay updated with the latest news on drug recalls and public health alerts. Visit trusted sources like the FDA website or your local pharmacy for real-time updates.
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The U.S. Food and Drug Administration has recalled over 580,000 bottles of prazosin hydrochloride due to a cancer-causing chemical. Patients should check their medication’s lot number and consult their pharmacist or healthcare provider for guidance.
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