Cipla Recalls Anti-Cancer Drug Nilotinib Due to Manufacturing Issue

Cipla’s US Arm Recalls Over 400 Cartons of Generic Anti Cancer Drug Nilotinib: USFDA​

Manufacturing Issue Triggers Recall of Nilotinib Capsules in Two Strengths​

New Delhi, March 8: Cipla’s US-based subsidiary has recalled more than 400 cartons of a generic anti cancer medication from the United States market due to a manufacturing-related issue, according to the US Food and Drug Administration.

In its latest enforcement report, the US health regulator stated that Cipla USA Inc., headquartered in Warren, New Jersey, initiated a recall of specific 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 drug.

Reason Behind the Cipla Drug Recall​

According to the USFDA, the affected batches were recalled because they did not meet the required tablet or capsule specifications during the manufacturing process.

Cipla USA began the voluntary recall on February 18, 2026. The regulator has classified the action as a Class III recall, indicating that the use of the product is unlikely to cause serious adverse health effects or major health consequences.

Role of Nilotinib in Cancer Treatment​

Nilotinib is a medication commonly used in cancer treatment. The drug functions by blocking the action of an abnormal protein that drives the growth and multiplication of cancer cells. By inhibiting this protein, Nilotinib helps slow or stop the spread of cancer cells within the body.

India’s Strong Presence in the US Pharmaceutical Market​

India continues to play a critical role in supplying medicines to the United States. The country hosts the highest number of USFDA compliant pharmaceutical manufacturing facilities outside the US.

Indian pharmaceutical companies are also key contributors to the American healthcare system, providing a large proportion of medicines used by patients across the country.

Industry data shows that Indian drugmakers were responsible for roughly four out of every ten prescriptions filled in the United States in 2022, highlighting their strong presence in the global generics market.

Earlier Recalls by Indian Drugmakers in the US​

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

The US regulator had then reported that the US-based arm of Sun Pharma recalled more than 26,000 bottles of a generic medication used for treating dandruff and inflammatory skin conditions that cause itching.