Lupin Pharmaceuticals is voluntarily recalling four lots of Quinapril Tablets to the patient (consumer/user) level due to the presence of a nitrosamine impurity, N-Nitroso-Quinapril, observed in recent testing above the Acceptable Daily Intake (ADI) level. To date, Lupin has received no reports of illness that appear to relate to this issue.

Lupin discontinued the marketing of Quinapril tablets in September 2022.

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.

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

Lupin Pharmaceuticals is notifying its wholesalers, distributors, drug chains, mail-order pharmacies and supermarkets by phone and through recall notification and is arranging for the return of all the recalled product lots.

Patients taking Quinapril tablets USP, 20mg, and 40mg are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding alternative treatment.

Wholesalers, distributors and retailers that have Quinapril Tablets USP, 20 mg and 40 mg that are being recalled should discontinue distribution of the recalled product lots immediately.