FDA Announces Recall of Blood Pressure Medication Over Contamination

The US Food and Drug Administration (FDA) has announced a significant recall of prazosin hydrochloride capsules, a medication commonly prescribed for high blood pressure and post-traumatic stress disorder (PTSD). This recall follows the detection of a nitrosamine impurity, a chemical linked to cancer, during routine testing. The voluntary recall, initiated by Teva Pharmaceuticals USA on October 7, 2025, impacts more than 580,000 bottles distributed across the United States.

Nitrosamines, a class of compounds that can pose a cancer risk in certain forms and concentrations, prompted the FDA to classify this recall as Class II on October 24, 2025. This classification indicates that while the recall involves products that may cause reversible side effects, there is no immediate risk of serious harm to patients.

Prazosin hydrochloride acts as an alpha-blocker, relaxing blood vessels to improve circulation and lower blood pressure. It is available in various strengths and is widely dispensed in pharmacies throughout the US. The contamination was discovered during routine quality control procedures, with certain batches showing nitrosamine levels exceeding acceptable daily intake limits. Such impurities can develop during manufacturing if chemical reactions are not adequately controlled or if raw materials are improperly managed over time.

Despite the low risk to patients, the presence of nitrosamines has raised concerns about production standards and quality assurance practices in the pharmaceutical industry. The FDA advises patients currently taking prazosin hydrochloride to consult with their healthcare provider or pharmacist to confirm whether their specific medication batch is affected. It is essential that patients do not stop their treatment abruptly without professional guidance.

This recall is part of a growing trend of pharmaceutical safety alerts in recent years. While previous incidents have involved nitrosamine impurities in other medications, such as certain blood pressure and diabetes drugs, other recalls have been due to different manufacturing issues. For instance, a recall involving atorvastatin in 2025 was linked to dissolution failures.

The recurrence of manufacturing-related recalls has intensified calls for stricter oversight of drug production and enhanced quality control systems. Experts emphasize that the ongoing issues highlight the need for improved transparency and consistency across global pharmaceutical supply chains.

The recall of prazosin hydrochloride serves as a critical reminder of the importance of rigorous quality control in drug manufacturing. While the immediate health risk from this contamination is low, it underscores the potential dangers that can arise with widely used medications. Patients are urged to verify their medications, discuss alternatives with their healthcare providers, and report any adverse reactions experienced.

The FDA continues to monitor the corrective actions taken by Teva Pharmaceuticals and is evaluating long-term safeguards to prevent future contamination incidents. The agency’s ongoing oversight aims to restore confidence in the safety and efficacy of medications available to the public.