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Lupin Pharmaceuticals has announced that it is voluntarily recalling four lots of Quinapril tablets, which are used in the treatment of hypertension and blood pressure, in the United States market due to the presence of a nitrosamine impurity.

The pharma major on Thursday stated that the impurity, N-Nitroso-Quinapril, was observed in recent testing above the Acceptable Daily Intake (ADI) level.

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

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The Mumbai-based company mentioned that it discontinued the marketing of Quinapril tablets in September 2022 and to date, it has received no reports of illness that appear to relate to this issue.

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.

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Quinapril tablet USP is an angiotensin-converting enzyme (ACE) inhibitor indicated for the treatment of hypertension to lower blood pressure.

While the company has asked wholesalers, distributors, and retailers to discontinue the distribution of recalled lots of quinapril tablets USP, 20 mg, and 40 mg immediately, it has asked patients to contact their pharmacist, physician, or medical provider for advice regarding alternative treatment.

Lupin develops and commercialises a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the US, India, South Africa, and across the Asia-Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

Shares of Lupin are trading 0.35 percent lower at Rs 763.60.

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(Edited by : Rukmani Krishna)