Lexington, Kentucky, October 31, 2025
A voluntary recall of over 580,000 bottles of prazosin hydrochloride, a blood pressure medication, has been announced in Lexington, Kentucky. The recall is due to the presence of potentially cancer-causing nitrosamine impurities. Teva Pharmaceuticals USA and Amerisource Health Services initiated the recall after an assessment by the FDA, which classified the affected lots as a Class II risk. Patients are urged to consult their healthcare providers for alternatives and are warned against discontinuing the medication without professional guidance.
Lexington, Kentucky: Blood Pressure Medication Recalled Over Cancer Concerns
Lexington, Kentucky – A voluntary recall has been initiated for over 580,000 bottles of prazosin hydrochloride, a blood pressure medication, due to the presence of potentially cancer-causing nitrosamine impurities. The recall was announced by Teva Pharmaceuticals USA and Amerisource Health Services, following an assessment by the U.S. Food and Drug Administration (FDA).
Details of the Recall
The affected lots of prazosin hydrochloride capsules have been classified by the FDA as a Class II risk, indicating a potential but not immediate threat to patient health. Nitrosamine impurities, such as N-nitrosamine, can form during drug manufacturing or storage processes and are considered potential human carcinogens.
Usage and Risks
Prazosin is commonly prescribed to lower blood pressure and manage sleep-related issues associated with post-traumatic stress disorder (PTSD). Patients currently taking this medication are advised to consult their healthcare providers for alternative treatments. Abruptly discontinuing the medication without professional guidance is not recommended.
Background on Nitrosamine Impurities
Nitrosamine impurities are a class of chemicals that can form during the manufacturing or storage of certain drugs. They have been identified as potential human carcinogens, leading to recalls of various medications in recent years. The FDA continues to monitor and assess the safety of pharmaceutical products to protect public health.
Recommendations for Affected Patients
Patients who have prazosin hydrochloride capsules from the affected lots should contact their healthcare providers to discuss alternative treatment options. It is important to follow medical advice and not to stop taking prescribed medications without professional consultation.
FDA’s Role and Ongoing Monitoring
The FDA plays a critical role in ensuring the safety and efficacy of medications available to the public. The agency continues to monitor the situation and will provide updates as more information becomes available. Patients are encouraged to report any adverse effects or concerns related to their medications to the FDA’s MedWatch program.
Conclusion
The recall of prazosin hydrochloride capsules underscores the importance of vigilance in pharmaceutical manufacturing and the need for ongoing monitoring to ensure public safety. Affected patients should seek guidance from their healthcare providers to determine the best course of action for their health and well-being.
Frequently Asked Questions (FAQ)
What is prazosin hydrochloride used for?
Prazosin hydrochloride is commonly prescribed to lower blood pressure and manage sleep-related issues associated with post-traumatic stress disorder (PTSD).
What are nitrosamine impurities?
Nitrosamine impurities are a class of chemicals that can form during the manufacturing or storage of certain drugs. They have been identified as potential human carcinogens, leading to recalls of various medications in recent years.
What should I do if I have prazosin hydrochloride capsules from the affected lots?
If you have prazosin hydrochloride capsules from the affected lots, contact your healthcare provider to discuss alternative treatment options. Do not stop taking prescribed medications without professional consultation.
How can I report adverse effects related to my medications?
Patients are encouraged to report any adverse effects or concerns related to their medications to the FDA’s MedWatch program.
Key Features of the Recall
| Feature | Details |
|---|---|
| Medication Affected | Prazosin hydrochloride capsules |
| Reason for Recall | Presence of potentially cancer-causing nitrosamine impurities |
| Number of Bottles Recalled | Over 580,000 |
| FDA Risk Classification | Class II risk |
| Recommended Action for Patients | Consult healthcare providers for alternative treatments; do not discontinue medication without professional guidance |
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