The US Food and Drug Administration (FDA) has confirmed a significant recall of prazosin hydrochloride capsules, a drug widely prescribed for high blood pressure and post-traumatic stress disorder (PTSD), after routine testing detected a nitrosamine impurity—a chemical linked to cancer.
The voluntary recall, initiated by Teva Pharmaceuticals USA on 7 October 2025, affects more than 580,000 bottles distributed nationwide. Nitrosamines are a class of compounds that, in certain forms and concentrations, are considered probable human carcinogens.
The FDA classified the recall as Class II on 24 October, indicating possible reversible side effects but no immediate risk of serious harm.
What is Prazosin and Why is It Prescribed?
Prazosin hydrochloride is an alpha-blocker that relaxes blood vessels, easing circulation and lowering blood pressure. It belongs to a class of medications known as alpha-blockers, which work by inhibiting specific nerve signals that cause blood vessels to constrict. The drug is available in multiple strengths and is widely dispensed at pharmacies across the US.
- Primary function: relaxes blood vessels and reduces cardiac strain.
- Secondary use: mitigates anxiety and nightmares in PTSD patients.
The recent contamination was discovered during routine quality testing. Nitrosamine levels in certain batches exceeded the acceptable daily intake limits. These impurities can form during the manufacturing process, especially when chemical reactions are not properly controlled or when raw materials and solvents are exposed to specific conditions over time. While the risk to patients is considered low, the presence of nitrosamines has prompted increased scrutiny of production standards and quality assurance practices.
Guidance for Patients
Patients currently taking prazosin hydrochloride should not stop treatment abruptly but should contact their doctor or pharmacist to confirm if their medication batch is affected.
- Check packaging: verify the manufacturer and batch number.
- Seek alternatives: your healthcare provider can prescribe substitute formulations.
- Report side effects: symptoms like nausea, dizziness, or blood pressure changes should be reported via the FDA MedWatch portal.
- Prompt medical guidance:it will help prevent complications and ensure your treatment remains safe and effective.
Broader Concerns Over Nitrosamine Contamination
This recall adds to a growing list of pharmaceutical safety alerts in recent years, though not all have involved the same contaminants.
While nitrosamine impurities have previously prompted recalls of medications, such as certain blood pressure and diabetes drugs, other recent recalls, including one involving atorvastatin in 2025, were due to different manufacturing issues, including dissolution failures.
These incidents have renewed calls for tighter oversight of drug production and more robust quality control systems. Experts say the recurrence of manufacturing-related recalls highlights the need for improved transparency and consistency across global pharmaceutical supply chains.
The recall of prazosin hydrochloride underscores the importance of rigorous quality control and transparency in drug manufacturing. While the immediate risk to patients is considered low, the incident serves as a reminder of the hidden dangers that can arise in widely used medications.
Conclusion
While the immediate health risk from prazosin contamination remains low, the recall underscores persistent gaps in pharmaceutical manufacturing oversight. Patients are urged to verify their medication, consult healthcare providers for alternatives, and report any adverse reactions.
The FDA continues to monitor Teva's corrective actions and evaluate long-term safeguards to prevent future contamination.
