Drug manufacturers have recalled more than 500,000 bottles of the blood pressure medication prazosin hydrochloride after discovering that some batches may contain a potentially cancer-causing chemical.
The U.S. Food and Drug Administration (FDA) confirmed that New Jersey-based Teva Pharmaceuticals USA and drug distributor Amerisource Health Services initiated voluntary nationwide recalls covering multiple doses of the medication, according to the Associated Press.
The companies said the affected capsules could contain nitrosamine impurities — specifically “No-nitroso Prazosin impurity C” — a substance considered a possible carcinogen. In total, around 580,000 bottles across various strengths have been recalled due to this contamination concern.
The FDA classified the recall as Class II, meaning “use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.”
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A statement from the California State Board of Pharmacy explained: “According to the Health Hazard Assessment by Teva USA, exposure to the product of concern could lead to severe adverse health consequences, but the likelihood of harm was assessed as remote. The overall risk of harm in the patient population is considered to be medium.”
The recall includes approximately 181,659 bottles of 1 mg capsules, 291,512 bottles of 2 mg capsules, and 107,673 bottles of 5 mg capsules. Each bottle may contain up to 1,000 capsules, with expiration dates ranging from November 2025 through February 2028.
The affected lot numbers and expiration dates are listed on the FDA’s website.
According to the AARP, anyone who possesses the recalled medication should contact their doctor or pharmacist for specific advice, return the medication to a pharmacy for proper disposal, and report any side effects or adverse reactions to the FDA.
The Mayo Clinic notes that prazosin is commonly prescribed to treat high blood pressure, or hypertension — a condition that can damage the heart, arteries, kidneys, and brain, and lead to complications such as stroke, heart failure, or kidney failure. It is also sometimes used to treat nightmares and other sleep disturbances linked to post-traumatic stress disorder, the AP reported.