The Food and Drug Administration (FDA) has ordered the recall of more than 580,000 bottles of prazosin hydrochloride capsules due to potential contamination with a carcinogenic substance. The medication, manufactured by Teva Pharmaceuticals USA and distributed by Amerisource Health Services, is used to treat hypertension and sleep disturbances linked to post-traumatic stress disorder.

The affected product comes in 1 mg, 2 mg, and 5 mg dosages. The FDA classified the recall as a Class II risk, indicating the medication may pose a temporary or reversible health threat. The agency cited concerns over nitrosamine impurities, which can form during manufacturing or storage. A failed impurity specification for N-nitroso Prazosin impurity C exceeded acceptable limits for carcinogenic potency, according to the recall notice.

Teva Pharmaceuticals has not publicly commented on the issue but advised patients to consult their pharmacies regarding remaining stock. The company sent recall instructions to customers and stated it has received no reports of adverse effects linked to the product. It emphasized that alternative treatments for hypertension are available and reiterated its commitment to patient safety.

The California Board of Pharmacy noted the potential harm to patients as moderate, though the FDA’s health hazard assessment remains pending. No further details on the extent of contamination or affected batches were disclosed in official statements.