The U.S. Food and Drug Administration (FDA) has provided details about three separate recalls for prazosin hydrochloride, a medication used to treat patients with hypertension, due to safety concerns. These are all Class II recalls. According to the FDA, this means taking the drug could lead to “temporary or medically reversible adverse health consequences” or a small possibility of “serious adverse health consequences.”
Prazosin hydrochloride is sold by Pfizer under the brand name Minipress. The drug included in these recalls, however, is a generic version sold by New Jersey-based Teva Pharmaceuticals USA.
Teva Pharmaceuticals is recalling more than 580,000 bottles of the drug. The voluntary recalls were put in place due to high levels of N-nitroso Prazosin impurity C, a potential carcinogen. Test results confirmed that the levels exceeded what the FDA allows according to its Carcinogenic Potency Categorization Approach.
These recalls were first initiated on Oct. 7. The FDA classified them as Class II incidents on Oct. 24.
In addition to being used as a hypertension treatment, prazosin hydrochloride has been associated with key benefits when prescribed to treat PTSD-related nightmares.