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Summary:

The FDA has announced a recall of over half a million bottles of the blood pressure medication prazosin hydrochloride due to concerns about potential contamination with cancer-causing nitrosamine impurities. The recall, initiated by Teva Pharmaceuticals USA and Amerisource Health Services, affects various strengths of the prazosin capsules, which are also sometimes prescribed for PTSD-related sleep disturbances. The FDA has classified the risk as Class II, indicating a potential for adverse health consequences.

News Article:

FDA Recalls Over Half-Million Bottles of Blood Pressure Drug Over Cancer Concerns

Copyright 2025 The Associated Press. All Rights Reserved.

WASHINGTON (AP) — The U.S. Food and Drug Administration (FDA) has announced the recall of more than half a million bottles of prazosin hydrochloride, a medication commonly used to treat high blood pressure, due to concerns about potential contamination with a cancer-causing chemical.

The nationwide recall, initiated by New Jersey-based Teva Pharmaceuticals USA and drug distributor Amerisource Health Services earlier this month, affects over 580,000 bottles of various strengths of prazosin capsules.

Prazosin is prescribed to relax blood vessels and lower blood pressure. It is also sometimes used to treat nightmares and other sleep disturbances associated with post-traumatic stress disorder (PTSD).

The FDA stated in online enforcement orders that the affected lots of the drug have been given a Class II risk classification. This classification indicates that exposure to the recalled medication may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote.

The agency cited the presence of nitrosamine impurities as the reason for the recall. N-nitrosamines are a class of chemicals that are considered potentially cancer-causing and can form during the manufacturing or storage of drugs.

The FDA advises patients taking prazosin to contact their doctor or pharmacist with any questions. The agency will continue to monitor the situation and provide updates as necessary.

(AP Photo/Jose Luis Magana, File) – FDA Seal

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