Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd....
FDA Recall #D-0381-2026 — Class III — February 18, 2026
Product Description
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
Reason for Recall
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Recalling Firm
Cipla USA, Inc. — Warren, NJ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
271 cartons - Ex: 84 outer cartons x 4 inner cartons x 4 blisters x 7 capsules
Distribution
U.S.A. Nationwide
Code Information
Lot #: 5GJ0220, 5GJ0221, 5GJ0222, Exp 04/30/2027
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated