WASHINGTON — The Food and Drug Administration has announced a nationwide recall of more than 580,000 bottles of prazosin hydrochloride, a prescription blood pressure medication, after tests found elevated levels of a cancer-causing impurity.
Teva Pharmaceuticals USA and Amerisource Health Services voluntarily issued the recall earlier this month. The FDA classified it as a Class II recall, meaning the product may cause temporary or reversible health effects, but the risk of serious harm is low.
The contamination involves N-nitroso Prazosin impurity C, a nitrosamine compound that can form during manufacturing or storage and is considered potentially carcinogenic.
The affected capsules range from 1 mg to 5 mg, sold under multiple lot numbers and expiration dates nationwide.
Health officials advise patients not to stop taking their medication without consulting a doctor or pharmacist.