Cipla Nilotinib Capsules Recalled for Stability Specification Failures

The US Food and Drug Administration (FDA) has classified a Class III recall for nilotinib capsules, 150 mg and 200 mg, manufactured by Cipla Ltd., Verna, Goa, India, and distributed by Cipla USA, Inc., Warren, NJ. The recall affects:

• Nilotinib 150 mg (NDC 69097-031-74), 271 cartons, Lots 5GJ0220, 5GJ0221, 5GJ0222, Exp. 04/30/2027
• Nilotinib 200 mg, 164 cartons, Lot 5GJ0223, Exp. 04/30/2027

Products were distributed nationwide in the USA. The recall was voluntarily initiated on February 18, 2026.

The recall was prompted by out-of-specification (OOS) results observed during 6-month long-term stability testing, specifically for the Description test and Appearance by Visual Inspection test. The FDA designated the action as Class III on March 3, 2026, indicating that the defect is unlikely to cause adverse health consequences but represents a failure to meet manufacturing quality standards. No public press release has been issued; notification was provided to consignees by letter.

Nilotinib is a tyrosine kinase inhibitor (TKI) indicated for the treatment of Philadelphia chromosome–positive chronic myeloid leukemia (CML) in certain patient populations. Stability-related description or appearance changes may affect product quality perception but are not expected to impact safety based on the Class III designation. Pharmacists should review inventory for affected lot numbers, quarantine impacted cartons, and coordinate replacement to ensure uninterrupted oncology therapy.

Reference

FDA. Enforcement Report. March 11, 2026. Accessed March 12, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm