Two major U.S. pharmaceutical distributors have recalled nearly 590,000 bottles of the blood pressure medication prazosin hydrochloride after federal regulators found the pills may contain nitrosamine impurities-a class of chemicals linked to cancer-at levels exceeding the agency's "acceptable intake limit."
The U.S. Food and Drug Administration (FDA) announced that Teva Pharmaceuticals USA and Amerisource Health Services initiated voluntary recalls in October after internal testing revealed the presence of N-nitroso prazosin impurity C, a chemical compound categorized as potentially carcinogenic. The FDA classified the recall as Class II, indicating that use of the affected medication "may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote."
According to the FDA's enforcement reports, Teva initiated its recall on October 7, while Amerisource followed on October 26, pulling 1mg, 2mg, and 5mg capsules of prazosin hydrochloride distributed nationwide. The vast majority-more than 580,000 bottles-were produced and distributed by Teva.
The medication, widely prescribed to treat hypertension, works by relaxing blood vessels and improving blood flow. It is also sometimes used off-label for post-traumatic stress disorder (PTSD) symptoms such as nightmares and sleep disturbances.
The FDA said that nitrosamine impurities can form during a drug's manufacturing or storage process. These chemicals have been detected in several medications in recent years, prompting global recalls of blood pressure and diabetes drugs. The agency emphasized that exposure to the impurities over long periods may increase the risk of cancer.
A Teva Pharmaceuticals spokesperson said in a statement to NBC Chicago that the company had not received any "relevant complaints" linked to the affected lots and was acting "out of an abundance of caution." "Teva prioritizes patient safety and product quality at every stage of a medicine's lifecycle," the company said. "Consumers with questions or concerns should also contact the health care provider who prescribed the medication."
Teva said it has sent recall notices to pharmacies and distributors with instructions for returning affected products. The company's Health Hazard Assessment classified the potential harm as "medium" for the patient population, according to a memo from the California Board of Pharmacy.
The FDA urged patients not to stop taking their medication without medical guidance, warning that "stopping your medicine may be more harmful to your health than continuing to take the recalled medicine" in some cases. Patients are advised to contact their healthcare provider or pharmacist to determine whether their medication is part of the affected lots.
Information on specific lot numbers, expiration dates, and package details for the recalled prazosin hydrochloride capsules is available on the FDA's website.
