Major Blood Pressure Medication Recall Due to Carcinogen Levels

Nearly 581,000 bottles of prazosin hydrochloride capsules, a medication used to treat high blood pressure, have been recalled following the discovery of potentially cancer-causing chemicals. The recall was initiated by Teva Pharmaceuticals on October 7, 2023, after tests revealed elevated levels of the impurity N-nitroso prazosin, which exceeds acceptable safety limits.

The United States Food and Drug Administration (FDA) classified this recall as a Class II risk on October 24. This classification indicates that exposure to the product “may cause temporary or medically reversible adverse health consequences” or that the likelihood of serious health consequences is low. The recall encompasses three dosage strengths of the drug, which is distributed nationwide.

Details of the Recall

Prazosin hydrochloride is primarily prescribed for high blood pressure and prostate conditions, though it is also used off-label to alleviate symptoms of post-traumatic stress disorder. The affected capsules include:

– **1 mg capsules**: 181,659 bottles (NDC 0093-4067-01 and 0093-4067-10) with lot numbers 3010544A and 3010545A, expiring in October 2025.
– **2 mg capsules**: 291,512 bottles (NDC 0093-4068-01 and 0093-4068-10) across multiple lot numbers with expiration dates ranging from October 2025 through July 2026.
– **5 mg capsules**: 107,673 bottles (NDC 0093-4069-01, 0093-4069-52, and 0093-4069-05) across multiple lot numbers with expiration dates extending into 2026.

The presence of N-nitroso compounds in medications has raised significant health concerns due to their classification as potential carcinogens.

Guidance for Patients

Patients currently taking the recalled medication are advised to consult their healthcare provider immediately. Discontinuing blood pressure medication suddenly can lead to health risks, including a spike in blood pressure levels. Teva Pharmaceuticals has informed customers via letter about the ongoing recall.

Individuals with questions regarding the recall should reach out to their pharmacist or healthcare provider to determine if their medication is impacted and to explore alternative treatment options. Maintaining open communication with healthcare professionals is essential for managing health effectively during this recall.