Millions of bottles of widely prescribed blood pressure medication, prazosin hydrochloride, have been recalled across the United States due to the detection of a potentially cancer-causing chemical impurity, N-nitroso Prazosin impurity C, at levels exceeding federal safety limits. The recall, initiated by Teva Pharmaceuticals USA and drug distributor Amerisource Health Services, affects nearly 590,000 bottles distributed nationwide.
Key Takeaways
- Recall Scope: Over 580,000 bottles of prazosin hydrochloride in 1 mg, 2 mg, and 5 mg strengths are affected.
- Contaminant: The impurity N-nitroso Prazosin impurity C, a type of nitrosamine, was found at unacceptable levels.
- Health Risk: Nitrosamines, in high concentrations and over prolonged exposure, may increase the risk of cancer.
- FDA Classification: The recall is classified as Class II, meaning potential adverse health consequences are temporary or medically reversible, with a remote probability of serious harm.
- Patient Guidance: Patients are strongly advised not to stop taking the medication without consulting their healthcare provider or pharmacist.
The Nature of the Contaminant
The impurity identified is N-nitroso Prazosin impurity C, a member of the nitrosamine family. Nitrosamines are chemicals that can form during the manufacturing or storage of certain drugs if chemical reactions or environmental conditions are not tightly controlled. While nitrosamines are commonly found in trace amounts in water, food, and air, the levels detected in the recalled prazosin capsules exceeded the acceptable daily intake limits set by regulatory agencies. The U.S. Food and Drug Administration (FDA) emphasizes that exposure to nitrosamines above acceptable levels over long periods may increase cancer risk.
Scope and Impact of the Recall
Teva Pharmaceuticals USA initiated the voluntary recall on October 7, 2025, with Amerisource Health Services following suit on October 26. In total, nearly 590,000 bottles across 55 separate lots are affected. The recalled bottles contain between 100 and 1,000 capsules each, with specific quantities for each strength: 181,659 bottles of 1 mg, 291,512 bottles of 2 mg, and 107,673 bottles of 5 mg.
Prazosin hydrochloride is a crucial medication used to relax blood vessels and lower blood pressure, thereby helping to prevent strokes, heart attacks, and kidney failure. It is also sometimes prescribed off-label to manage nightmares and sleep disturbances associated with post-traumatic stress disorder (PTSD).
