Cipla Recalls Cancer Drug Nilotinib Capsules Due to Manufacturing Issue

A U.S.-based subsidiary of pharmaceutical company Cipla is voluntarily recalling over 400 cartons of its generic anti-cancer medication, Nilotinib Capsules, due to a manufacturing issue, according to the U.S. Food and Drug Administration (FDA).

Details of the Recall

Cipla USA, Inc., located in Warren, Latest Jersey, is recalling Nilotinib Capsules in two strengths: 150 mg and 200 mg. The recall affects 271 and 164 cartons, respectively. The FDA stated the recall is due to “failed tablet/capsule specifications.”

The company initiated the Class III voluntary recall on February 18, 2026. A Class III recall, as defined by the FDA, occurs when the utilize or exposure to a violative product is not likely to cause adverse health consequences.

What is Nilotinib?

Nilotinib works by blocking the action of an abnormal protein that signals cancer cells to multiply, thereby helping to stop or leisurely the spread of cancer cells. It is used in the treatment of chronic myeloid leukemia (CML).

Cipla and the U.S. Pharmaceutical Market

India is a significant supplier of pharmaceuticals to the United States. In 2022, Indian companies supplied approximately 40% of all prescriptions filled in the U.S. India has the highest number of pharmaceutical plants compliant with U.S. FDA standards outside of the U.S.

Product Information

Cipla Nilotinib Capsules are available in 50mg, 150mg, and 200mg strengths. Cipla USA, Inc. Can be contacted at 844-CIPLA US (844-247-5287) or via email at Cipla.CS@cipla.com.

Disclaimer: This article provides information based on publicly available sources as of March 8, 2026. It is not intended as medical advice.