FDA Announces Recall of Over 580,000 Bottles of Blood Pressure Drug Due to Cancer Risk

Nationwide Recall Issued for Prazosin Hydrochloride

The U.S. Food and Drug Administration (FDA) has announced a nationwide recall affecting more than 580,000 bottles of prazosin hydrochloride capsules, a medication commonly prescribed for high blood pressure. The recall, initiated by Teva Pharmaceuticals USA and distributed by Amerisource Health Services, stems from the detection of a potentially cancer-causing chemical impurity.

The affected medication contains elevated levels of N-nitroso Prazosin impurity C, which belongs to a group of chemicals known as N-nitrosamines. These impurities are considered potential carcinogens and may increase cancer risk if exposure occurs above acceptable levels over prolonged periods.

Class II Recall Classification and Patient Guidance

The FDA has classified this as a Class II recall. This classification indicates a situation where '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.'

The recall impacts prazosin hydrochloride capsules in 1 mg, 2 mg, and 5 mg doses. Teva Pharmaceuticals USA voluntarily initiated the recall on October 7, 2025, with the FDA classifying it on October 24, 2025.

Patients currently taking prazosin hydrochloride are advised to consult their doctor or pharmacist if they have questions or concerns. Neither the FDA nor Teva has explicitly recommended that patients stop taking the recalled medication without medical advice, as 'stopping your medicine could be more dangerous for you than continuing.' Patients can check the lot number on their prescription bottles to determine if their medication is included in the recall.

About Prazosin Hydrochloride

Prazosin hydrochloride is an alpha-blocker primarily approved to treat high blood pressure by relaxing blood vessels and improving blood flow. It is also used off-label for other conditions, including:

• Post-traumatic stress disorder (PTSD) related nightmares
• Benign enlarged prostate
• Temporary discoloration of the extremities due to cold exposure

The presence of nitrosamine impurities can occur during the manufacturing or storage process of a drug. The FDA continues to monitor such situations to ensure drug safety and maintain rigorous testing standards for pharmaceuticals.