Quick Read
- Nearly 590,000 bottles of prazosin hydrochloride were recalled due to nitrosamine impurities exceeding FDA safety limits.
- The recall affects 1mg, 2mg, and 5mg capsules distributed by Teva Pharmaceuticals USA and Amerisource Health Services.
- Nitrosamines are potentially cancer-causing chemicals that can form during drug production or storage.
- The FDA classified the recall as Class II, indicating low but present health risk.
- Patients are advised not to stop their medication abruptly and to consult their healthcare provider.
Why Was Prazosin Hydrochloride Recalled?
In October 2025, nearly 590,000 bottles of prazosin hydrochloride—a widely prescribed blood pressure medication—were recalled across the United States. The recall was initiated by Teva Pharmaceuticals USA and Amerisource Health Services after U.S. Food and Drug Administration (FDA) enforcement reports found that specific lots of the drug contained nitrosamine impurities above what is considered an acceptable intake limit.
Nitrosamines are a group of chemicals that, according to the FDA, may cause cancer if people are exposed to them at high enough levels over extended periods. These impurities can form unintentionally during drug manufacturing or storage, making them a growing concern in the pharmaceutical industry.
Teva Pharmaceuticals USA, based in New Jersey, accounted for most of the recalled bottles—over 580,000—while Amerisource Health Services distributed the remainder. The affected capsules are prazosin hydrochloride in 1mg, 2mg, and 5mg strengths, and the recall only applies to select lot numbers and expiration dates.
Which Lots Are Affected?
The recall covers specific batches, including lot numbers 1016996, 1018336, and 1021220 (expiring November 30, 2025), as well as lot numbers 1022421 and 1025017 (expiring August 31, 2026). Patients who have received prazosin hydrochloride should check their medication against these lot numbers and expiration dates, which can be found on the bottle labels.
The FDA classified the recall as Class II, meaning that while the probability of serious adverse health consequences is considered remote, there is still a risk of temporary or medically reversible health effects. This classification is important because it guides both the urgency of the recall and the advice given to patients.
The Role and Risks of Nitrosamine Impurities
Nitrosamines have come under increased scrutiny in recent years. According to NewsNation and Reuters, these chemicals are not unique to prazosin—they’ve been detected in other medications as well. Nitrosamines can form during the manufacturing process or even while drugs are in storage, sometimes as a result of chemical reactions between ingredients.
The FDA’s Carcinogenic Potency Categorization Approach (CPCA) sets a threshold for how much of these impurities can be present before a product is considered unsafe. If the level exceeds this threshold, the product must be recalled to protect public health.
While the long-term risks of nitrosamine exposure depend on the amount and duration, the FDA emphasizes that the risk from the recalled prazosin lots is considered low but not negligible.
What Is Prazosin Used For?
Prazosin is primarily prescribed to relax blood vessels, helping to lower blood pressure. But its uses extend beyond hypertension. Some doctors prescribe prazosin for patients suffering from nightmares and sleep disturbances related to post-traumatic stress disorder (PTSD), making it an essential medication for many.
Given its broad utility, the recall has raised concerns among patients who rely on prazosin for daily well-being.
What Should Patients Do?
If you have prazosin hydrochloride capsules at home, the FDA recommends checking the bottle for the affected lot numbers and expiration dates. If your medication matches the recall criteria, do not stop taking it abruptly. The FDA warns that “stopping your medicine may be more harmful to your health than continuing to take the recalled medicine,” especially for those managing high blood pressure or PTSD.
Instead, contact your healthcare provider or pharmacist as soon as possible. They can advise you on next steps, which may include switching to a different batch or an alternative medication. Pharmacies are prepared to help patients identify affected products and facilitate safe replacements.
For more details, patients can consult the FDA’s enforcement reports, which list all recalled lot codes and expiration dates.
Industry Response and Regulatory Oversight
Both Teva Pharmaceuticals USA and Amerisource Health Services have stated that the recall is voluntary and nationwide. Their rapid response demonstrates the importance of robust quality control and transparency in the pharmaceutical industry.
Regulatory agencies like the FDA continue to monitor drug safety closely. The recent recall highlights the evolving challenges drugmakers face in preventing and detecting impurities, especially those that pose long-term health risks.
Broader Implications for Medication Safety
The prazosin recall is not an isolated event. In recent years, recalls due to nitrosamine contamination have affected other blood pressure medications, such as valsartan and losartan. This pattern points to the need for ongoing vigilance and improvements in manufacturing standards.
For patients, these recalls underscore the importance of being informed and proactive about medication safety. Regularly checking lot numbers and consulting with healthcare professionals can help minimize risks.
How Should Patients Weigh Their Options?
Ultimately, patients face a difficult choice: continue taking a recalled medication or risk interrupting treatment for conditions like hypertension or PTSD. The FDA’s guidance is clear—do not make sudden changes without consulting a doctor.
Health professionals can assess individual risks and recommend the safest course of action, whether that involves switching medications or continuing with careful monitoring.
Where to Find Reliable Information
Patients looking for more information can visit the FDA website, which provides comprehensive enforcement reports. Pharmacies and healthcare providers are also valuable sources for guidance and support.
As drug recalls become more common, the ability to quickly identify affected products and respond appropriately is vital for both public health and individual well-being.
The prazosin hydrochloride recall highlights a crucial tension in modern healthcare: balancing patient safety against the risks of treatment interruption. While the presence of nitrosamine impurities is concerning, the measured response from regulators and manufacturers, as well as clear communication to patients, reflects a system striving to protect people without causing unnecessary alarm. Ultimately, this event is a reminder of the importance of transparency, vigilance, and informed decision-making in every aspect of medical care.