The US Food and Drug Administration (FDA) has declared that more than 580,000 bottles of a common blood pressure medication have been recalled due to contamination with a potentially cancer-causing chemical.
The recall covers various strengths of “Prazosin Hydrochloride” capsules. The drug is commonly used to treat high blood pressure and prostate conditions, and is also sometimes prescribed off-label for PTSD-related nightmares.
New Jersey-based Teva Pharmaceuticals USA initiated the recall earlier this month. On October 24, the FDA classified it as a Class II recall.
Why Prazosin Hydrochloride Was Recalled
As noted in the FDA enforcement report, testing of the medication revealed that the capsules contained elevated levels of an impurity known as “N-nitroso prazosin.”
The chemical structure is R2N−N=O, where R is usually an alkyl group. Nitrosamines have a nitroso group (NO+) that are “probable human carcinogens” attached to a deprotonated amine. Most nitrosamines are carcinogenic in animals.
Their opportunity for formation can be during the manufacturing process or during storage.
The FDA explained that exposure to this chemical “may cause temporary or medically reversible adverse health consequences or where the likelihood of serious health consequences is small.”
What medication is affected?
The recall spans three different dosage strengths of Prazosin Hydrochloride capsules that were distributed nationwide. The affected products are:
- 181,658 bottles of 1 mg capsules with lot numbers 3010544A and 3010545A expiring in October 2025.
- 291,512 bottles of 2 mg capsules across multiple lot numbers, with expiration dates from October 2025 to July 2026.
- 107,673 bottles of 5 mg capsules across multiple expiration dates extending into 2026.
What patients should do
Patients should not abruptly stop their medication as this can pose serious health threats. The FDA recommends patients take the following steps:
- Contact your doctor immediately to find out if your prescription drug is part of the recalled lots.
- Ask your doctor about a safe alternative.
- Discontinue medication under the direct supervision of a healthcare professional
Other common medications like Zantac have also been recalled due to nitrosamine impurities in the past.
