FDA recalls ‘Prazosin Hydrochloride' blood pressure medication over cancer risk

U.S. Food and Drug Administration (FDA) has declared more than 580,000 bottles of a common blood pressure medication have been pulled from the market due to contamination with a potentially cancer-causing chemical.

The recall includes various strengths of “Prazosin Hydrochloride” capsules. The drug is commonly used to treat high blood pressure and prostate conditions, which 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, FDA classified it as a Class II recall.

Why Prazosin Hydrochloride was recalled

As mentioned in the enforcement report of FDA, the 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,” bonded to a deprotonated amine. Most nitrosamines are carcinogenic in animals.

Their possibility of formation can be during the manufacturing process or during storage.

FDA explained that exposure to this chemical “may cause temporary or medically reversible adverse health consequences or where the probability of serious health consequences is remote.”

Which medications are 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 2mg capsules across multiple lot numbers, with expiration dates from October 2025 through July 2026.
• 107,673 bottles of 5 mg capsules across multiple expiry dates extending into 2026. 

What patients should do

Patients should not abruptly stop their medication as it can pose serious health threats. FDA recommends patients to take following steps:

• Immediately consult your doctor to get to know if your specification medication is part of recalled lots.
• Ask your doctor about any safer alternative option.
• Discontinue medicine under direct supervision of a healthcare professional

Other common medications like Zantac have also been recalled due to nitrosamine impurities in the past.