Product: NILOTINIB Classification: Class III 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. 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 Recalling firm: Cipla USA, Inc. Product type: Drugs
FDA MedWatch published a clinical safety alert in Pharmacology on 11 Mar 2026.
The item focuses on NILOTINIB: Class III recall update.
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