FDA Issues Recall of Prazosin Hydrochloride Due to Cancer Risk

Silver Spring, Maryland — The U.S. Food and Drug Administration announced the voluntary recall of more than 500,000 bottles of prazosin hydrochloride, a medication used primarily to treat high blood pressure. The recall was initiated by New Jersey-based Teva Pharmaceuticals USA and drug distributor Amerisource Health Services due to concerns that the medication may contain a cancer-causing chemical.

The companies reported that the affected capsules may have impurities known as nitrosamines, specifically ‘No-nitroso Prazosin impurity C,’ which are classified as potentially cancer-causing. In total, about 580,000 bottles across various strengths have been recalled.

The FDA has categorized this recall as Class II, indicating that exposure to the violated product might result in temporary health issues, but the likelihood of serious health consequences is considered low. According to a Health Hazard Assessment from Teva USA, while the potential for severe health consequences exists, the overall risk of harm to patients remains medium.

The recall affects multiple strengths of the medication: 181,659 bottles of 1 mg, 291,512 bottles of 2 mg, and 107,673 bottles of 5 mg — each bottle containing up to 1,000 capsules. The expiration dates of these bottles range from November 2025 to February 2028.

Patients who have been prescribed prazosin hydrochloride are advised to contact their healthcare providers or pharmacists for specific guidance regarding this recall. The FDA recommends returning any affected medication to the pharmacy for safe disposal and reporting any adverse side effects.

Prazosin is commonly prescribed to manage high blood pressure, a condition that can strain the heart and bloodstream, leading to severe complications like stroke and kidney failure. It is also used for treating sleep disturbances related to post-traumatic stress disorder.