FDA Warns of Cancer-Linked Impurities in Popular Blood Pressure Medicine.
Health The U.S. Food and Drug Administration (FDA) has announced a major recall of more than 500,000 bottles of the blood pressure medication prazosin hydrochloride, citing the presence of N-nitrosamines, chemical compounds associated with an increased risk of cancer.
The recall, initiated by Teva Pharmaceuticals, applies to 1 mg, 2 mg, and 5 mg tablets of prazosin hydrochloride, an FDA-approved alpha-blocker commonly prescribed to treat high blood pressure and, in some cases, PTSD-related nightmares and prostate issues.
According to the FDA’s enforcement notice, the recall is categorized as a Class 2 event, meaning the medication “may cause temporary or medically reversible adverse health consequences,” though the likelihood of serious harm is considered remote.
The affected lots were found to contain elevated levels of N-nitrosamine impurities, specifically “N-nitroso Prazosin impurity C.” Nitrosamines are environmental contaminants found in water, certain foods, and cured meats, but at high levels in medications, they pose long-term carcinogenic risks.
The FDA emphasized that the danger arises primarily from sustained exposure over time, not short-term use.
While Teva and the FDA have not issued direct instructions for patients to discard the medication, pharmacists advise consumers to check the lot number on their prescription bottles and consult their doctor or pharmacist before making any changes.
“Stopping your blood pressure medication suddenly can be more dangerous than continuing it,” noted a Harvard Health report cited by the agency.
Teva has not confirmed how the impurities formed but said it is cooperating with regulators to remove affected products from circulation.
The FDA added that such impurities can develop during manufacturing or prolonged storage, particularly under certain temperature or chemical conditions.
Health experts recommend that patients continue their prescribed treatment until they speak with their healthcare provider. Pharmacists can help verify whether a specific batch number falls under the recall list available on the FDA website.
The recall underscores a growing concern in the U.S. pharmaceutical supply chain, where nitrosamine contamination has triggered multiple recalls over the past five years, including for blood pressure and diabetes medications.
For patients, vigilance remains key: check your lot number, contact your pharmacist, and seek medical guidance before stopping any medication.
