New Delhi: A US-based subsidiary of Cipla has recalled more than 400 cartons of a generic anti-cancer medicine due to a manufacturing issue, according to the US Food and Drug Administration (USFDA). 

In its latest enforcement report, the US health regulator said that Cipla USA, Inc, based in Warren, New Jersey, is recalling certain batches of Nilotinib Capsules in two strengths -- 150 mg and 200 mg.

The recall involves 271 cartons of one batch and 164 cartons of another batch of the medicine.

The USFDA said the company decided to recall the affected lots because they failed to meet the required tablet or capsule specifications during manufacturing.

Cipla USA initiated the voluntary recall on February 18, 2026. The regulator classified it as a Class III recall, which means the use of the product is unlikely to cause serious health problems or adverse health consequences.

Nilotinib is a medication used in cancer treatment. It works by blocking the action of an abnormal protein that causes cancer cells to grow and multiply. By blocking this protein, the drug helps slow down or stop the spread of cancer cells in the body.

India remains a key supplier of medicines to the US market. The country has the highest number of USFDA-compliant pharmaceutical manufacturing plants outside the United States.

Indian drugmakers also play a major role in the American healthcare system, supplying a large share of medicines used by patients in the country.

According to industry data, Indian pharmaceutical companies accounted for about four out of every 10 prescriptions filled in the US in 2022 -- highlighting their significant presence in the global generics market.

Meanwhile, in January this year, Sun Pharmaceutical Industries and Cipla recalled certain products from the US market due to manufacturing-related issues.

The US health regulator had said the US-based arm of Mumbai-headquartered Sun Pharma is recalling more than 26,000 bottles of a generic medicine used to treat dandruff and skin conditions that cause inflammation and itching.