FDA recalls blood pressure medication due to impurity, cancer risks

We’re told no illnesses have been reported as of Dec. 21

Quinapril tablet USP recalled for nitrosamine impurity (Credit: FDA) (WSLS)

Four lots of Quinapril Tablets are being recalled by Lupin Pharmaceuticals Inc. due to the presence of a nitrosamine impurity, N-Nitroso-Quinapril, according to the FDA.

Officials found the impurity in recent testing, which they say is above the acceptable daily intake level.

We’re told the impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time, but as of Dec. 21, Lupin has received no reports of illness that appear to relate to this issue.

The Quinapril tablet USP is a medicine used as a treatment of hypertension – to lower blood pressure, the FDA said.

The tablets, 20mg and 40mg, are packaged in 90-count bottles and were distributed nationwide in the US to wholesalers, drug chains, mail-order pharmacies, and supermarkets, officials said.

You can find information on the recalled lots from the FDA below:

ProductLot NoExpiryNDCUPCDistribution Dates
Quinapril Tablets USP, 20mgG10292904/202368180-558-09

Quinapril Tablets USP, 40mgG100533


The FDA said if you’re taking tablets included in the recall, you’re advised to continue taking your medication and contact your pharmacist, physician, or medical provider for advice regarding alternative treatment.

If you have questions about the recall, you can contact Inmar Rx Solutions, Inc. at (877) 538-8445 Monday through Friday from 9:00 a.m. to 5:00 p.m. EST, the FDA said.

Additionally, officials said that adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting in any of the following ways:

  • Complete and submit the report here or here
  • Regular mail or fax: Download the form here or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

About the Author:

Alli Graham came aboard the digital team as an evening digital content producer in June 2022.