Daijiworld Media Network - New Delhi
New Delhi, Mar 8: A US-based subsidiary of Cipla has recalled more than 400 cartons of a generic anti-cancer medication from the American market after a manufacturing-related issue was detected, according to the US Food and Drug Administration (USFDA).
In its latest enforcement report, the US health regulator said that Cipla USA, headquartered in Warren, New Jersey, has recalled certain batches of Nilotinib capsules available in two strengths — 150 mg and 200 mg.
The recall covers 271 cartons from one batch and 164 cartons from another batch of the medicine.
According to the USFDA, the company initiated the recall after the affected lots failed to meet required capsule specifications during the manufacturing process. Cipla USA began the voluntary recall on February 18, 2026.
The regulator classified the action as a Class III recall, indicating that the use of the product is unlikely to cause serious health problems or significant adverse health consequences.
Nilotinib is used in cancer treatment and works by blocking the activity of an abnormal protein that causes cancer cells to grow and multiply. By inhibiting this protein, the drug helps slow or stop the spread of cancer cells in the body.
India continues to be a major supplier of medicines to the United States. The country hosts the largest number of USFDA-compliant pharmaceutical manufacturing facilities outside the US, highlighting its importance in the global generics supply chain.
Indian pharmaceutical companies also play a significant role in the US healthcare system. Industry data shows that Indian drugmakers accounted for roughly four out of every ten prescriptions filled in the US in 2022, underscoring their strong presence in the global generics market.
Earlier this year, Sun Pharmaceutical Industries and Cipla had also recalled certain products from the US market over manufacturing-related concerns.
In January, the USFDA reported that the US-based arm of Sun Pharma recalled more than 26,000 bottles of a generic medication used to treat dandruff and inflammatory skin conditions.