In a significant development impacting hundreds of thousands of patients, nearly 590,000 bottles of high blood pressure medication have been recalled in the United States due to potential contamination with a cancer-causing impurity.
The recalls, initiated by Teva Pharmaceuticals USA and Amerisource Health Services, involve various lots of Prazosin Hydrochloride, a commonly prescribed drug used to manage hypertension and other related conditions.
The high blood pressure medication recalls were first initiated on October 7, 2025, when Teva Pharmaceuticals voluntarily pulled back approximately 580,844 bottles of the drug from distribution.
Shortly after, Amerisource Health Services followed with its own recall on October 26.
According to reports published by the U.S. Food and Drug Administration (FDA), the affected capsules were found to contain N-nitrosamine impurities above the agencyβs acceptable intake limits – a serious concern as these compounds are classified as potential carcinogens.
Understand the Contamination
N-nitrosamines are a group of chemical compounds known to increase cancer risk with prolonged exposure.
These impurities can form unintentionally during the manufacturing or storage process of certain medications.
The FDA has emphasized that the impurity found in this case – N-nitroso Prazosin impurity C – exceeded the agencyβs Carcinogenic Potency Categorization Approach (CPCA) limit, prompting immediate action from drug manufacturers and regulators alike.
The FDA classified the current situation as a Class II recall, which indicates that while the product may cause temporary or medically reversible health effects, the likelihood of serious health consequences remains remote.
Still, health experts stress the importance of vigilance, particularly among individuals who have been taking Prazosin regularly for managing chronic high blood pressure.
Impacted Products and Patients
The high blood pressure medication recalls apply specifically to Prazosin Hydrochloride capsules available in 1mg, 2mg, and 5mg doses.
A total of 55 production lots have been recalled so far. Both Teva and Amerisource distributed these medications nationwide, meaning the recall could potentially affect patients across the United States.
Prazosin is widely prescribed as an alpha-blocker, helping to relax blood vessels and reduce blood pressure levels.
Beyond hypertension, it is sometimes used for post-traumatic stress disorder (PTSD) to manage nightmares and sleep disturbances.
Because of its wide application, health officials are urging patients to check the lot numbers and expiration dates of their current prescriptions against those listed in the FDAβs enforcement reports.
What Patients Should Do Next
Both the FDA and Teva Pharmaceuticals have released statements advising patients not to stop taking their medication abruptly without consulting their healthcare providers.
For many, discontinuing blood pressure medication suddenly could pose greater health risks than continuing the affected treatment temporarily.
Teva has assured consumers that no complaints or adverse events have been reported so far related to the impurity.
The company has also sent recall notices to pharmacies and distributors with detailed return instructions for the recalled products.
Patients are advised to contact their pharmacists or healthcare providers to verify whether their medication is part of the recall and to discuss alternative treatment options if necessary.
Industry-Wide Implications
This latest case adds to a growing list of pharmaceutical recalls linked to nitrosamine contamination in recent years.
Just last month, a popular cholesterol drug, Lipitor, was recalled for dissolution issues, raising further questions about manufacturing quality control within the pharmaceutical industry.
Experts note that while the FDA and drug manufacturers continue to refine their monitoring systems, these high blood pressure medication recalls highlight the ongoing challenges of maintaining safety standards in complex drug production environments.
As investigations continue, the FDA reassures patients that it remains committed to ensuring that all recalled medications are removed from circulation and that future manufacturing processes are closely monitored to prevent similar incidents.
For now, patients affected by the high blood pressure medication recalls should remain informed, follow medical advice, and prioritize open communication with their healthcare providers to ensure continued, safe management of their blood pressure.
