The Food and Drug Administration (FDA) has ordered a recall of over 580,000 bottles of prazosin hydrochloride capsules due to potential contamination with a carcinogenic substance. The voluntary nationwide recall was initiated by New Jersey-based drugmaker Teva Pharmaceuticals USA and distributor Amerisource Health Services earlier this month.
The medication, available in 1 mg, 2 mg, and 5 mg doses, is used to lower blood pressure and treat sleep disturbances linked to post-traumatic stress disorder. The FDA classified the affected batches as a Class II recall, indicating the product may cause temporary health issues or pose a remote risk of serious harm. The agency identified nitrosamine impurities in some lots, which can form during manufacturing or storage.
Teva Pharmaceuticals has not commented publicly on the recall but advised patients to contact their pharmacies for guidance. The company stated it has received no reports of adverse effects linked to the medication and emphasized that alternative treatments are available. The FDA’s health hazard assessment deemed the risk to patients as moderate.
The recall notice highlighted violations of impurity specifications, with certain batches exceeding acceptable limits for N-nitroso prazosin, a compound classified as potentially carcinogenic. Patients were urged to consult their healthcare providers for further instructions.
