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WASHINGTON — In a significant development affecting patients across the nation, Teva Pharmaceuticals has recalled nearly 581,000 bottles of prazosin hydrochloride, a drug commonly prescribed for high blood pressure. This move comes after tests detected levels of potentially cancer-causing chemicals that exceed safety standards.
Teva announced the voluntary recall of the capsules on October 7. The U.S. Food and Drug Administration (FDA) subsequently classified the recall as a Class II risk as of October 24. This classification suggests that the use of the affected medication could lead to temporary or medically reversible adverse health effects, though the likelihood of severe health consequences is considered low.
The recall encompasses three different dosage strengths of prazosin hydrochloride that have been distributed nationwide. While primarily used to manage symptoms of high blood pressure and certain prostate conditions, prazosin hydrochloride is also occasionally prescribed for alleviating symptoms of post-traumatic stress disorder (PTSD).
According to the FDA report, the recalled batches contain elevated levels of N-nitroso prazosin, an impurity that poses potential health risks. Patients currently taking the medication are advised to consult with their healthcare providers for guidance and alternative treatment options.
The recalled capsules contain elevated levels of N-nitroso prazosin impurity, according to the FDA report.
Recalled medications
- 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.
What patients should do
Patients taking the recalled medication should consult their healthcare provider as soon as possible, as suddenly discontinuing blood pressure medication can pose health risks.
The company has notified customers by letter and the recall remains ongoing. Patients with questions about the recall should contact their pharmacist or healthcare provider to determine whether their medication is affected and discuss alternative treatment options.
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