Pfizer Issues Voluntary Recall of Blood Pressure Tablets Due to High Levels of Nitrosamine

Pfizer has issued a voluntary recall of Accuretic (quinapril HCl/hydrochlorothiazide) tablets distributed by Pfizer as well as two authorized generics distributed by Greenstone (quinapril and hydrochlorothiazide and quinapril HCl/hydrochlorothiazide) on a consumer level due to the presence of a nitrosamine, N-nitroso-quinapril, that is above the Acceptable Daily Intake (ADI) level. The recall includes six lots of Accuretic tablets, one lot of quinapril and hydrochlorothiazide tablets, and four lots of quinapril HCl/hydrochlorothiazide tablets.

The tablets are used for the treatment of hypertension, focused on lowering blood pressure to reduce the risk of cardiovascular issues. There have been no reports to Pfizer of any adverse effects that have resulted from the products in this recall. Pfizer has stated that there is no immediate risk to patients taking the medication in a press release.

Nitrosamines are common in things people come in contact with every day, such as water and certain foods like grilled meats and dairy products. Everyone is exposed to some level of nitrosamines, though long-term exposure of them that exceed the ADI level may increase the risk of cancer, according to the company.

The product lots were distributed nationwide to distributers and wholesalers in the United States and Puerto Rico from November 2019 to March 2022. Pfizer has issued letters to entities in possession of these lots for the return of the recalled product.

Source: FDA