Class IIIOngoing

Nilotinib Capsules recall

FDA recall D-0381-2026 · initiated Feb 18, 2026

Unlikely to cause harm but violates FDA labeling or manufacturing regulations.

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.

Details

Product: 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 company: Cipla Limited
Classification: Class III
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: U.S.A. Nationwide
Initiated: Feb 18, 2026
FDA report date: Mar 11, 2026

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0381-2026 ↗

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