---
title: "Cipla's US unit recalls 400+ cartons of generic anti-cancer drug: USFDA"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/278249419.md"
description: "Cipla USA, Inc, a subsidiary of Cipla, is recalling over 400 cartons of Nilotinib Capsules (150 mg and 200 mg) due to manufacturing issues, as reported by the USFDA. The Class III voluntary recall, initiated on February 18, indicates that exposure to the product is not likely to cause adverse health consequences. Nilotinib is used to block cancer cell multiplication. Indian pharmaceutical companies play a significant role in supplying medications to the US market, with a substantial share of prescriptions filled by them in 2022."
datetime: "2026-03-08T05:34:43.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/278249419.md)
  - [en](https://longbridge.com/en/news/278249419.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/278249419.md)
---

# Cipla's US unit recalls 400+ cartons of generic anti-cancer drug: USFDA

A US-based subsidiary of drugmaker Cipla is recalling over 400 cartons of generic anti-cancer medication due to a manufacturing issue, according to the US Food and Drug Administration (USFDA).

Warren (New Jersey)-based Cipla USA, Inc is recalling Nilotinib Capsules in two strengths (150 mg and 200 mg), the US health regulator said in its latest Enforcement Report.

The company is recalling the affected lot (271 and 164 cartons) due to "failed tablet/capsule specifications", it stated.

Cipla USA, Inc initiated the Class III voluntary recall on February 18 this year.

According to the USFDA, a Class III recall is initiated in a "situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences".

 

Nilotinib works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps to stop or slow the spread of cancer cells.

India has the highest number of USFDA-compliant pharmaceutical plants outside of the US.

Indian pharmaceutical companies supply a substantial proportion of drugs to US residents, with four out of 10 of all prescriptions filled in the US in 2022 being supplied by Indian companies.

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