The U.S. Food and Drug Administration (FDA) announced that more than 580,000 bottles of the blood pressure medication prazosin hydrochloride have been recalled due to concerns that some batches may contain a potentially cancer-causing impurity.
According to The Associated Press, the recall was issued voluntarily earlier this month by Teva Pharmaceuticals USA, based in New Jersey, and drug distributor Amerisource Health Services, according to FDA enforcement reports.
Prazosin is commonly prescribed to lower blood pressure by relaxing blood vessels and improving blood flow. Doctors also sometimes use it to treat nightmares or sleep disturbances related to post-traumatic stress disorder (PTSD).
The FDA said the affected lots of the medication have been given a Class II recall classification, meaning the drug may cause temporary or medically reversible health effects, but the probability of serious harm is remote. The recall was prompted after testing indicated that some capsules might contain nitrosamine impurities, which are considered potentially carcinogenic.
“N-nitrosamine impurities are a class of potentially cancer-causing chemicals that can form during manufacture or storage of a drug,” the FDA said in a statement.
The agency noted that while everyone is exposed to some level of nitrosamines through food, water, and other sources, long-term exposure to higher levels can increase the risk of cancer.
The FDA said it continues to work closely with manufacturers to identify the source of contamination and prevent similar issues in the future. Patients taking prazosin are advised not to stop the medication abruptly without consulting their healthcare provider, as sudden discontinuation could lead to dangerous spikes in blood pressure.
The agency has posted full details about the recalled lots and dosage strengths on its official recall database.
