FDA recalls more than 580,000 bottles of blood pressure medicine after finding cancer-causing impurity

In another round of recalls, a blood pressure medication is being pulled from shelves across the U.S. due to serious health concerns. The FDA previously recalled a batch of Atorvastatin tablets, a cholesterol-lowering drug, earlier this month.

The nationwide recall was announced by the U.S. Food and Drug Administration (FDA) for more than 580,000 bottles of “prazosin hydrochloride capsules” - a drug distributed by Teva Pharmaceuticals USA.

The drug, used to treat high blood pressure - even PTSD-related symptoms - contained trace levels of a potentially cancer-causing chemical, according to the FDA.

FDA issues Class II recall after impurity detected

Teva issued the voluntary recall on 7 October. On 24 October, the FDA classified it as a Class II risk - meaning the drug, if consumed, could cause “temporary or medically reversible health issues”, though serious harm is unlikely.

According to the FDA report, the recalled drug contained nitrosamine impurities - identified as “N-nitroso Prazosin impurity C”. Nitrosamines are classified as possible human carcinogens, and long-term exposure to them could increase the risk of cancer in patients consuming the drug.

More than 580,000 bottles pulled from shelves

Prazosin hydrochloride is typically prescribed to relax blood vessels, enhance circulation, and lower blood pressure. Doctors also use it - off-label - to treat PTSD-related symptoms and sleep disturbances. Per the FDA’s recall notice, the affected products are as follows:

181,659 bottles of 1 mg capsules

291,512 bottles of 2 mg capsules

107,673 bottles of 5 mg capsules

Each bottle can contain between 100 and 1,000 capsules, depending on the packaging.

So far, neither Teva nor the FDA has reported any illnesses linked to the recalled medication, according to USA Today. However, the FDA has urged patients and healthcare providers to review the lot numbers listed on the agency’s Enforcement Report before continuing to use it.

What patients should do if they have recalled medicine

No official disposal instructions have been released. However, GoodRx - a digital healthcare platform - recommends checking the label, contacting a pharmacist or the prescriber, and safely disposing of any affected medication. Patients are advised not to stop taking their blood pressure medicine without consulting a doctor.

Teva Pharmaceuticals has not issued a public comment beyond the recall notice. For more details, consumers can refer to the FDA’s Enforcement Report or consult their local pharmacy for guidance.

FAQs

What blood pressure medicine is being recalled?

Teva Pharmaceuticals’ prazosin hydrochloride capsules in 1 mg, 2 mg, and 5 mg strengths.

Why did the FDA recall the medicine?

Tests found traces of N-nitroso Prazosin impurity C, a cancer-linked nitrosamine.

How many bottles are affected by the recall?

Over 580,000 bottles across all strengths, distributed nationwide.

What should patients do if they have the recalled drug?

Check the lot number, contact your pharmacist or doctor, and dispose of the recalled bottles safely.