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.
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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).
Guidance for Patients and Healthcare Providers
Both the FDA and Teva Pharmaceuticals are urging patients currently taking the recalled prazosin to consult their healthcare provider or pharmacist before discontinuing the medication. Stopping treatment abruptly could pose a greater health risk than continuing to take the medication, depending on the individual’s condition. Healthcare providers are encouraged to discuss alternative treatment options with their patients.
Teva Pharmaceuticals has stated its commitment to patient safety and product quality, noting that it had not received any relevant complaints related to the recalled product. Recall letters have been sent to customers with instructions for returning affected bottles.
