Blood Pressure Drug Recall Over Cancer Risk

©Author: TendingGB | publish : 31 Oct 2025

More than half a million bottles of the blood pressure medication prazosin hydrochloride have been recalled across the United States due to the discovery of elevated levels of a potentially cancer-causing impurity. The recall, involving approximately 581,000 bottles, was issued by Teva Pharmaceuticals on October 7 and later classified as a Class II recall by the U.S. Food and Drug Administration (FDA) on October 24.

The FDA’s Class II designation means that the use or exposure to the affected medication may cause temporary or medically reversible health consequences, and the likelihood of serious adverse effects is considered remote. Still, the presence of N-nitroso prazosin, a nitrosamine impurity, raised concern because such substances are known to increase the risk of cancer when present above acceptable limits or with prolonged exposure.

The recall covers three dosage strengths of the drug: 

1 mg, 2 mg, and 5 mg capsules. These capsules were distributed nationwide through pharmacies and healthcare providers. According to the FDA, nitrosamine impurities like N-nitroso prazosin can form during the manufacturing process or while the drug is stored under certain conditions, such as high temperature or humidity.

Prazosin is widely prescribed to manage high blood pressure (hypertension) by relaxing blood vessels, allowing blood to flow more easily. It is also used to treat prostate enlargement and is sometimes prescribed off-label for managing post-traumatic stress disorder (PTSD), particularly for patients experiencing nightmares or sleep disturbances.

For patients currently taking prazosin hydrochloride, experts emphasize that they should not stop the medication abruptly. Doing so may lead to dangerous spikes in blood pressure or other cardiovascular complications. Instead, patients are advised to consult their healthcare provider or pharmacist immediately to determine whether their specific medication is part of the recall and to discuss alternative treatment options.

Teva Pharmaceuticals has already notified distributors and customers through official recall letters, and the recall process is still ongoing. Pharmacies and wholesalers have been instructed to stop distributing the affected lots and return them to the company. Patients or healthcare professionals with questions can contact Teva’s customer service for more information about the recall and next steps.

This is not the first time that medications have been recalled due to nitrosamine contamination. Over the past few years, similar recalls have affected several blood pressure and heart medications, including valsartan and losartan. Regulatory agencies worldwide, including the FDA and the European Medicines Agency, continue to monitor and tighten manufacturing standards to minimize the risk of such impurities in pharmaceuticals.

While the FDA continues to investigate the source of the impurity in prazosin hydrochloride, it has reaffirmed that the risk to patients is relatively low in the short term. Still, the agency maintains that drug manufacturers must take every possible step to ensure product safety and quality.

Consumers are encouraged to report any adverse reactions or quality issues related to the recalled medication through the FDA’s MedWatch Safety Information and Adverse Event Reporting Program. This helps the agency track potential health impacts and ensure that appropriate regulatory actions are taken promptly.

The recall serves as a reminder of the importance of strict quality control and monitoring in the pharmaceutical industry, particularly when it comes to drugs used for long-term conditions like hypertension. Patients are urged to remain cautious, stay informed, and maintain open communication with their healthcare providers.