Cipla’s U.S. Unit Recalls More Than 400 Cartons of Anti-Cancer Drug Nilotinib
NEW DELHI — A U.S.-based subsidiary of Cipla has recalled more than 400 cartons of a generic anti-cancer medication due to a manufacturing issue, according to the U.S. Food and Drug Administration.
In its latest enforcement report, the regulator said 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 from one batch and 164 cartons from another batch of the medication.
The FDA said the company initiated the recall after the affected lots failed to meet required tablet or capsule specifications during the manufacturing process.
Cipla USA began the voluntary recall on Feb. 18, 2026. The regulator classified it as a Class III recall, meaning use of the product is unlikely to cause serious health problems or 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 targeting this protein, the drug helps slow or stop the spread of cancer cells in the body.
India remains a major supplier of medicines to the U.S. market and has the largest number of FDA-compliant pharmaceutical manufacturing plants outside the United States.
Indian drugmakers also play a significant role in the U.S. healthcare system, supplying a large share of medicines used by patients across the country.
Industry data shows Indian pharmaceutical companies accounted for roughly four out of every 10 prescriptions filled in the United States in 2022, underscoring their major presence in the global generics market.
Earlier this year, both Sun Pharmaceutical Industries and Cipla recalled certain products from the U.S. market because of manufacturing-related issues.
In January, the FDA said the U.S.-based arm of Mumbai-headquartered Sun Pharma recalled more than 26,000 bottles of a generic medicine used to treat dandruff and inflammatory skin conditions. (Source: IANS)
