Cipla USA Recalls Nilotinib Anti-Cancer Capsules Over Manufacturing Issue: USFDA
A United States-based subsidiary of Cipla has initiated a recall of certain batches of its generic anti-cancer medication Nilotinib Capsules following a manufacturing issue, according to the U.S. Food and Drug Administration (USFDA).The recall, issued
A United States-based subsidiary of Cipla has initiated a recall of certain batches of its generic anti-cancer medication Nilotinib Capsules following a manufacturing issue, according to the U.S. Food and Drug Administration (USFDA).
The recall, issued by Cipla USA Inc., involves more than 400 cartons of Nilotinib capsules in 150 mg and 200 mg strengths, which were distributed in the United States. The action was triggered after the affected batches were found to have failed tablet or capsule specification requirements during manufacturing, the US health regulator said in its latest enforcement report.
According to regulatory disclosures, the recall includes 271 cartons from one batch and 164 cartons from another, and was initiated voluntarily by the company on February 18, 2026.
The USFDA classified the action as a Class III recall, indicating that the use of the product is unlikely to cause adverse health consequences but does not meet regulatory manufacturing standards.
Nilotinib is a targeted therapy used in the treatment of Philadelphia chromosome-positive chronic myeloid leukemia (CML), a cancer that affects blood and bone marrow. The drug works by blocking abnormal proteins that signal cancer cells to grow and multiply, helping to slow or stop disease progression.
The recall highlights the strict compliance framework governing pharmaceutical manufacturing in regulated markets such as the United States, where drug makers must adhere to Good Manufacturing Practices (GMP) and quality specifications monitored by the USFDA.
India remains one of the largest suppliers of generic medicines to the US market, with Indian pharmaceutical manufacturers operating a significant number of USFDA-compliant production facilities outside the United States. Industry data indicates that Indian companies account for a substantial share of prescriptions filled in the US healthcare system, underscoring the global importance of India’s pharmaceutical manufacturing ecosystem.
Regulatory experts note that such recalls are part of routine quality monitoring processes designed to ensure drug safety, efficacy, and compliance with international manufacturing standards.
