FDA Class II Recall of Blood Pressure Medication Updated as Quiramed Voluntarily Recalls Quinapril Tablets

The U.S. Food and Drug Administration has classified a nationwide recall of a blood pressure medication as a Class II risk level, according to a notice published on the agency’s website. The recall involves quinapril tablets manufactured by Quiramed, a generic drug maker, and was initiated after the discovery of a nitrosamine impurity known as N-nitroso-quinapril above acceptable daily limits.

The FDA announced the Class II designation on September 24, 2025, following the company’s voluntary recall on August 28, 2025. A Class II classification means the product may cause temporary or medically reversible adverse health consequences, but the probability of serious harm is remote.

The affected lots include quinapril tablets in 10 mg, 20 mg, and 40 mg strengths, distributed nationwide to wholesalers, retailers, and pharmacies. Quiramed has not issued a public statement beyond the FDA enforcement report, which lists the recalled lots and expiration dates.

The FDA advises patients who have the recalled medication to continue taking it until they consult with their healthcare provider, as abruptly stopping blood pressure medication can lead to dangerous health events. Patients should contact their pharmacist or doctor for a replacement or alternative therapy.

This recall is part of a broader, ongoing effort by the FDA to monitor and limit nitrosamine impurities in commonly prescribed medications. The agency has issued similar recalls for other drugs in recent years, including valsartan, losartan, and metformin. No adverse events related to this specific recall have been reported to the FDA as of the latest update.

Consumers and healthcare professionals can report adverse reactions or quality problems to the FDA’s MedWatch program. The enforcement report for this recall is available on the FDA’s website, and Quiramed has set up a dedicated recall hotline for questions.