NILOTINIB
Recalling Firm / Manufacturer: Cipla USA, Inc.
(Warren, NJ, United States)
FDA Recall Number: D-0381-2026
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
NILOTINIB
Generic Name
NILOTINIB
Active Substance(s)
Nilotinib
Administration Route
Oral
National Drug Code (NDC)
69097-030
Total Quantity Recalled
271 cartons - Ex: 84 outer cartons x 4 inner cartons x 4 blisters x 7 capsules
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Full Product Description
Packaging specifications and labeling details
Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, Outer carton: 112 capsules (4 individual packs containing 28 capsules each) NDC 69097-031-74; Inner carton: 28 capsules (4 blisters of 7 capsules) NDC 69097-031-56; Foil blister: NDC 69097-031-17
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class III
Current Action Status
Ongoing
FDA Enforcement Report Date
March 11, 2026
Firm Initiation Date
February 18, 2026
FDA Classification Date
Mar 03, 2026
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot #: 5GJ0220, 5GJ0221, 5GJ0222, Exp 04/30/2027
Distribution Information
Geographic scope of affected shipments
U.S.A. Nationwide
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Advisory Notice
This Class III recall involves technical or packaging non-conformities that are not expected to cause adverse health consequences. Consult your pharmacist if you have questions.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0381-2026
Questo Retrieval Date: July 31, 2026 14:36 1785508606UTCC