Drug Safety Alerts

FDA Issues Consumer-Level Recall on Quinapril 20 mg and 40 mg Tablets

12/21/2022

On December 21, 2022, the United States Food and Drug Administration (FDA) published a notice regarding a consumer-level recall of Quinapril 20 mg and 40 mg tablets manufactured by Lupin Pharmaceuticals Inc. This recall was issued due to the presence of a nitrosamine impurity, N-Nitroso-Quinapril, observed in recent testing above the Acceptable Daily Intake (ADI) level.

This could be a health hazard or safety risk to patients who may be using product affected by this recall.

See a complete list of the affected products and lot numbers.

Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.

Quinapril tablet USP is an angiotensin-converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Quinapril Tablets USP 20mg, and 40mg is packaged in 90 count bottles and was distributed nationwide in the US to wholesalers, drug chains, mail order pharmacies and supermarkets.

The FDA recommends that patients continue taking their medication and contact their medical provider for advice regarding an alternative treatment.

CVS Caremark Response: Because of this action, CVS Caremark is contacting patients and prescribers to advise them of this recall. We are encouraging patients who are taking Quinapril 20 mg and/or 40 mg tablets to contact their prescriber.

For more information about this recall, please call Lupin Medical Information toll-free at 1-800-399-2561. You may also call the FDA consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit the FDA web site.