Cipla’s US subsidiary has recalled more than 400 cartons of a generic anti-cancer drug in the United States following a manufacturing issue, according to the U.S. Food and Drug Administration (USFDA).

The recall involves Nilotinib capsules in two strengths—150 mg and 200 mg—distributed in the US market. The affected batches include a total of 435 cartons, comprising 271 cartons from one lot and 164 from another.

The regulator said the recall was initiated after the product failed to meet tablet or capsule specifications during manufacturing.

Cipla’s US arm, based in Warren, New Jersey, voluntarily initiated the recall on February 18, 2026. The action has been classified as a Class III recall by the USFDA, indicating that the use of the affected product is unlikely to cause adverse health consequences.

Nilotinib is used in the treatment of certain types of cancer and works by blocking abnormal proteins that drive cancer cell growth.

The development comes as Indian pharmaceutical companies continue to play a significant role in supplying medicines to the US market, with a large share of prescriptions filled using generics manufactured by Indian firms.