Blood pressure medicine recall 2022: Company, tablets, and everything to know amid potential cancer risk

On October 24, 2022, the FDA announced that Aurobindo Pharma USA, Inc. initiated a voluntary recall of one of its blood pressure medications due to its potential cancer risk.

The multinational pharmaceutical company recalls two lots of quinapril and hydrochlorothiazide tablets from the U.S. market due to unacceptable levels of nitrosamines.

The medicine is used to treat hypertension by lowering blood pressure.

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Blood pressure pills exposed to nitrosamines taken over long periods of time can increase the risk of cancer

The pharmaceutical company states that it is recalling the medication out of caution. It reports:

"(we have) initiated a voluntary recall of two (2) lots of Quinapril and Hydrochlorothiazide Tablets USP 20mg / 12.5mg, to the retail level from the US market due to presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Quinapril above the proposed interim limit."

Aurobindo Pharma USA, Inc. began shipping the batches in question, QE2021005-A, and QE2021010-A, to consumers across the United States in May 2021. It has an expiration date of January 2023.

The pills in question are:

“Pink colored, scored, round shaped, biconvex, film-coated tablets, debossed with ‘D’ on scored side and ‘19’on other side”, supplied in 90’s HDPE bottle."

Photo of the medication package (Image via Aurobindo USA)

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What is the risk?

According to the press release, everyone is exposed to some levels of nitrosamine, or N-nitroso-quinapril. It is regularly found in water and food, including vegetables, cured and grilled meats, and dairy products. But exposure to high levels is "linked with an elevated risk of cancer."

However, no adverse effects have been seen or reported as yet due to the issue. Nevertheless, patients are advised by the FDA's website to:

"contact their doctor or health care provider about whether to continue taking their medication, or whether to consider an alternative treatment prior to returning their medication."

The press release further requested consumers with any medical questions in regards to the recall of the said blood pressure pills or to report an adverse effect to contact the company directly at

1. Call at 1-866-850-2876 (Option 2), 24 hours per day, seven days per week; or
2. Send an email to [email protected]

Qualanex is recalling the blood pressure pills on behalf of Aurobindo Pharma USA, Inc., and will notify its distributors and customers in writing as well as by phone.

Any questions in reference to the recall can be directed at Qualanex (1-888-504-2014) Monday to Friday between 7.00 am to 4.00 pm Central Standard Time.

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Aurobindo Pharma Limited is an Indian multinational pharmaceutical company headquartered in Hyderabad, India. It has operations across the globe, including in the United States, where it has its U.S. Corporate Headquarters in East Windsor, New Jersey.

In 2018 and 2019, the company previously recalled certain medications due to the presence of NDEA, which is a "probable human carcinogen."