The FDA reported exceeding permissible levels of a substance linked to the risk of cancer

According to the FDA, the drug contained «exceedance of permissible limits» of the nitrosamine called N-nitroso Prazosin impurity C — a class of chemical substances associated with an increased risk of cancer. The recall was officially classified as Class II, meaning that the potential for serious harm is considered remote, but still of medical concern.

Although the FDA’s classification of the recall as Class II means that most people are unlikely to experience serious consequences, the agency warns that «temporary or medically reversible adverse health effects» may occur. Teva noted that alternative methods for treating hypertension remain widely available and reaffirmed its commitment to quality control, stating: «Patients have access to a variety of alternative treatment methods».

«Teva prioritizes patient safety and product quality at every stage of the drug’s life cycle».

The compound N-nitroso Prazosin impurity C may form during the manufacturing or storage process