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FDA Recalls Over 580,000 Bottles of Blood Pressure Medication Due to Impurity Concerns
Published: October 31, 2025
By: Health Desk
The U.S. Food and Drug Administration (FDA) has announced a nationwide recall of more than 580,000 bottles of Prazosin Hydrochloride, a commonly prescribed medication used to treat high blood pressure. The recall was initiated after routine testing detected unsafe levels of a potentially carcinogenic impurity known as “N-nitroso Prazosin impurity C.”
Details of the Recall
The affected medication includes 1 mg, 2 mg, and 5 mg capsule strengths, sold in bottle sizes ranging from 100-count to 1,000-count. The impacted products carry expiration dates between October 2025 and February 2027.
According to the FDA, the impurity levels found in these batches exceeded the acceptable safety limits set by the Carcinogenic Potency Categorization Approach (CPCA). Although the impurity poses a low cancer risk at minimal exposure, the detected amounts violated manufacturing quality standards.
Recall Classification
This recall has been classified as a Class II recall, meaning the use of the affected medicine may lead to temporary or reversible health issues, but the risk of severe harm is considered low.
Officials emphasized that patients should not stop taking the medication abruptly, as doing so could worsen their blood pressure condition. Instead, patients are advised to consult their doctor or pharmacist to arrange a safe replacement.
What Patients Should Do
If you have Prazosin Hydrochloride at home:
Check the label for the affected batch numbers and expiration dates.
Stop using the recalled medicine once confirmed.
Return the product to the pharmacy or place of purchase for a replacement.
For any health-related concerns, contact your healthcare provider immediately.
Pharmacies and distributors have been instructed to remove the recalled lots from circulation and coordinate returns with the manufacturer.
FDA Contact Information
For additional details or assistance regarding this recall, you can reach the FDA at:
📞 1-888-INFO-FDA (1-888-463-6332)
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Source: FDA Safety Notice & Official Recall Reports
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