Cipla USA, Inc. recalls Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India, M…

Recall date

February 18, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0381-2026

FDA classification

Class III

Brand / firm

Cipla USA, Inc.

Sold / distributed

U.S.A. Nationwide

Why it was recalled

Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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