A US-based subsidiary of Cipla has recalled over 400 cartons of a generic anti-cancer drug due to a manufacturing problem, as reported by the US Food and Drug Administration (USFDA). Cipla USA, Inc, located in Warren, New Jersey, is recalling specific batches of Nilotinib Capsules in strengths of 150 mg and 200 mg, involving 271 cartons of one batch and 164 cartons of another. The recall was initiated because the affected lots did not meet the required tablet or capsule specifications during production.
Cipla USA began the voluntary recall on February 18, 2026, with the USFDA categorizing it as a Class III recall, indicating that using the product is unlikely to result in serious health issues. Nilotinib, the medication in question, is utilized in cancer treatment by inhibiting the action of an abnormal protein that promotes cancer cell growth and multiplication, thereby aiding in slowing down or halting cancer cell spread in the body.
India continues to be a significant supplier of medicines to the US market, boasting the highest number of USFDA-compliant pharmaceutical manufacturing facilities outside the US. Indian pharmaceutical companies play a crucial role in the American healthcare system, supplying a substantial portion of medications consumed by patients in the country. Industry data reveals that Indian pharmaceutical firms filled approximately 40% of prescriptions in the US in 2022, underscoring their substantial presence in the global generics market.
In a separate incident earlier this year, Sun Pharmaceutical Industries and Cipla also recalled certain products from the US market due to manufacturing-related issues. The US health regulator disclosed that the US-based division of Sun Pharma is recalling over 26,000 bottles of a generic medicine used for treating dandruff and skin conditions causing inflammation and itching.
