Cipla Recalls Over 400 Cartons of Cancer Drug in US Following Manufacturing Issue
Cipla’s US subsidiary has voluntarily recalled certain batches of Nilotinib capsules after failing to meet manufacturing specifications, according to the USFDA
- By PharmaNews Live Desk
- New Delhi
- Mar 09, 2026
Indian pharmaceutical company Cipla’s US-based subsidiary has initiated a recall of more than 400 cartons of a generic anti-cancer medication in the United States following a manufacturing issue identified by the US Food and Drug Administration (USFDA).
According to the regulator’s latest enforcement report, Cipla USA Inc., headquartered in Warren, New Jersey, is recalling certain batches of Nilotinib capsules, a medicine used in cancer treatment.
The recall involves two strengths of the drug — 150 mg and 200 mg capsules — distributed in the US market.
Manufacturing specifications triggered recall
The USFDA noted that the affected batches were withdrawn after they failed to meet required manufacturing specifications during quality checks.
The recall covers 271 cartons from one batch and 164 cartons from another batch, bringing the total to more than 400 cartons.
Cipla USA initiated the voluntary recall on February 18, 2026, according to the USFDA enforcement report.
Classified as Class III recall
The USFDA classified the action as a Class III recall, which typically indicates that the use of or exposure to the product is “not likely to cause adverse health consequences.”
Such recalls are generally initiated when a product deviates from manufacturing specifications but is unlikely to pose serious health risks to patients.
Role of the drug in cancer treatment
Nilotinib is used in the treatment of certain cancers and works by blocking the activity of abnormal proteins that cause cancer cells to grow and multiply. By inhibiting this process, the drug helps slow or stop the spread of cancer cells in the body.
Indian pharma’s presence in the US market
The development highlights the extensive role Indian pharmaceutical manufacturers play in supplying medicines to the US healthcare system. India hosts the largest number of USFDA-compliant pharmaceutical manufacturing facilities outside the United States, and Indian companies supply a significant share of medicines used in the American market.
Industry data indicates that four out of ten prescriptions filled in the US in 2022 were supplied by Indian pharmaceutical companies, underscoring the scale of India’s presence in global generics manufacturing.