• Source: azat.tv

Teva Pharmaceuticals has recalled more than 500,000 bottles of the blood pressure drug prazosin hydrochloride after tests showed the presence of cancer-linked impurities at levels above acceptable limits, according to the U.S. Food and Drug Administration (FDA).

The recall, issued as a Class 2 event, includes 1, 2, and 5 milligram (mg) doses of prazosin hydrochloride. The medication, an alpha-blocker, is commonly prescribed to manage high blood pressure and is also used off-label for conditions such as benign prostatic hyperplasia (enlarged prostate), nightmares associated with post-traumatic stress disorder (PTSD), and temporary cold-induced discoloration of fingers or toes.

What the recall means?

In its enforcement report, the FDA classified the event as a Class 2 recall, which applies to drugs that may cause temporary or medically reversible health effects. It also applies when the likelihood of serious health consequences is considered remote.

Neither Teva Pharmaceuticals nor the FDA has directed blood pressure drug to immediately stop taking the recalled medication. The agency noted that in Class 2 recalls, discontinuing treatment can sometimes pose greater risks than continuing, especially for people managing chronic conditions like hypertension.

“Patients should contact their doctor or pharmacist if they have concerns about their medication,” the FDA said in its report. “They can provide guidance on whether to continue treatment or seek alternatives.”

Source of the contamination

Testing revealed the presence of N-nitrosamines, a class of chemical compounds linked to increased cancer risk when exposure occurs at high levels over long periods. Nitrosamines can form during the manufacturing process or when drugs are stored under certain conditions.

According to the FDA, N-nitrosamines are also found in common foods such as cured meats, dairy products, and vegetables, as well as in water. “Everyone is exposed to some level of nitrosamines,” the agency said, adding that the goal is to minimize exposure from medicines to as low as reasonably possible.

The FDA emphasized that the cancer risk from short-term exposure remains low. The agency explained that if a person took a drug containing nitrosamines at or below the acceptable daily intake every day for 70 years, they would not be expected to have an increased cancer risk.

Checking affected lots

Consumers can verify whether their blood pressure drug is part of the recall by checking the lot number printed on the bottle label. The FDA’s recall database includes a full list of affected products. Pharmacies and healthcare providers have been notified to identify and remove impacted lots from distribution.

Teva Pharmaceuticals has not yet provided details on the root cause of the contamination or on corrective actions being taken at its manufacturing facilities. The company said it is cooperating with regulatory authorities to ensure compliance and safety in future production runs.

Broader industry concerns

Nitrosamine contamination has prompted several drug recalls in recent years, affecting blood pressure medications, diabetes drugs, and antacids. The FDA has since tightened oversight of manufacturing processes and issued guidance to help companies identify and control potential sources of impurities.

Experts say the ongoing recalls highlight the challenges of maintaining quality control in global pharmaceutical supply chains. Many drugs are produced or sourced from multiple facilities around the world, increasing the complexity of oversight.

For now, health officials stress that patients should not stop taking prazosin or any prescribed medication without consulting their healthcare provider. “The risk of uncontrolled blood pressure drug can be serious,” the FDA said. “Any changes to treatment should be made under medical supervision.”