The Food and Drug Administration (FDA) announced 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 treat hypertension and has been prescribed for 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 poses a remote risk of serious harm.
The agency cited concerns over nitrosamine impurities, which can form during manufacturing or storage. A Health Hazard Assessment by Teva USA noted the potential harm to patients is moderate. The company advised users to contact their pharmacies and return the medication, emphasizing that no adverse complaints have been reported.
Teva stated alternative treatments are available for hypertension and reiterated its commitment to patient safety. The recall includes specific lots of prazosin hydrochloride, with detailed instructions provided to customers.