The Food and Drug Administration confirmed in several notices that a recall of a type of high blood pressure medication has been expanded due to the presence of a potentially carcinogenic substance.

In three notices issued this week, the FDA confirmed that 7,198 cartons of prazosin hydrochloride are being recalled nationwide by Ohio-based Amerisource Health Services and classified the recall as Class II.

N-nitroso prazosin, a nitrosamine found in the medication, is above the FDA’s acceptable limits, according to the FDA. Nitrosamines are a type of organic compound that is a potential human carcinogen that can form in food or other substances.

A Class II recall is considered by the FDA to be a serious but less severe product safety recall for a product that may cause temporary or medically reversible adverse health consequences or if there is a remote chance of a serious adverse health consequence associated with the item.

Latest Drugs Under Recall

The three items are:

• Prazosin Hydrochloride capsules USP in 1-milligram doses in 100-capsule (10x10) cartons, which are distributed by American Health Packaging. It has a Carton NDC of 68084-996-01, and it has individual unit doses of NDC 68084-996-11.


• Prazosin Hydrochloride capsules USP in 2-milligram doses in 100-capsule (10x10) cartons, which are distributed by American Health Packaging. It has a Carton NDC of 68084-997-01, and it has individual unit doses of NDC 68084-997-11.


• Prazosin Hydrochloride capsules USP in 5-milligram doses in 20-capsule (5x4) cartons, which are distributed by American Health Packaging. It has a Carton NDC of 60687-572-32, and it has individual unit doses of NDC 60687-572-33.

The FDA did not include any other information about the recalled items, including whether people should continue taking them. In numerous previous recalls for products that contain elevated nitrosamine levels, the FDA has generally advised people to continue taking the prescription medication.

Other Lots Recalled Over Nitrosamines

Last month, New Jersey-based Teva Pharmaceuticals USA issued a nationwide recall of more than 580,000 bottles of various strengths of prazosin capsules, according to the FDA.

The FDA said in enforcement orders uploaded online that it has also given the affected lots of the drug a Class II risk classification because some of the recalled medication may have similar nitrosamine impurities.

The notices did not say why the recalled bottles contained nitrosamine impurities above the FDA’s acceptable levels. However, a webpage that includes information about nitrosamine impurities in medications on the agency’s website says that there are several possible reasons.

“The source of nitrosamines can be related to the drug’s manufacturing process or its chemical structure or even the conditions in which they are stored or packaged,” the webpage says. “As foods and drugs are processed in the body, nitrosamines can also be formed. FDA continues to test and research possible sources for drugs found to contain nitrosamines.”

What Is Prazosin?

Prazosin hydrochloride, which is sometimes sold under the brand name Minipress, is used primarily to treat hypertension, or high blood pressure, but it’s also prescribed to treat post-traumatic stress disorder (PTSD) and nightmares.

An article published by Scientific American found that as many as 20 percent of U.S. military veterans treated through the Department of Veterans Affairs (VA) take prazosin.

An alpha blocker is a type of medication that blocks a hormone that causes blood vessels to narrow, thereby relaxing muscles in the blood vessel walls and widening them, according to the Mayo Clinic’s website.