Recall on 500,000 Bottles of Blood Pressure Medication Escalated to Higher Risk Level
The U.S. Food and Drug Administration (FDA) has raised concerns over a major recall involving more than half a million bottles of blood pressure medication. The decision comes after tests revealed contamination in certain batches of prazosin hydrochloride, a prescription drug commonly used to manage hypertension.
Company behind the recall
Teva Pharmaceuticals USA, based in New Jersey, initially issued the recall earlier this month. The company distributed the medication nationwide and took action following reports of impurities detected during quality control evaluations.
FDA reclassifies the risk level
The FDA has since elevated the recall to a Class II risk category. This classification indicates that use of the affected medication could result in temporary or medically reversible adverse effects, though it is not expected to cause lasting harm in most cases.
Details of the affected batches
The recall includes 1-milligram, 2-milligram, and 5-milligram capsules of prazosin hydrochloride. These were sold in bottles containing 100, 250, 500, or 1,000 capsules, with expiration dates between October 2025 and February 2027.
Nature of the contamination
Testing revealed higher-than-permitted levels of an impurity identified as “N-nitroso Prazosin impurity C.” According to the FDA, this compound exceeds the safety limit established under the Carcinogenic Potency Categorization Approach (CPCA).
Health concerns associated with impurities
Although the FDA has not reported any immediate injuries or illnesses linked to the contaminated medication, the presence of nitrosamine-based impurities can be concerning. Prolonged exposure to such substances has been associated with an increased risk of cancer.
Response from Teva Pharmaceuticals
Teva has stated that it is cooperating fully with federal authorities to ensure affected products are removed from circulation. The company has also initiated measures to strengthen its testing processes and prevent future occurrences.
Guidance for consumers
Patients currently taking prazosin hydrochloride are urged not to stop their medication abruptly without consulting their healthcare provider. The FDA has not yet issued specific instructions regarding the return or disposal of the recalled capsules.
Pharmacists’ role in the recall
Pharmacies and distributors have been notified of the recall and are expected to identify and separate the affected lots. Healthcare professionals are encouraged to communicate with patients who may have received these medications.
Regulatory oversight and next steps
The FDA continues to monitor the situation closely as Teva works to complete the recall process. Further updates or additional safety notices may be issued if new information becomes available.
A broader reminder on medication safety
This incident underscores the importance of routine quality testing and vigilance within the pharmaceutical supply chain. Patients are encouraged to stay informed about product recalls and to regularly review medication alerts from the FDA’s official channels.
