Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Nilotinib Capsules Recalled by Cipla USA, Inc. Due to Failed Tablet/Capsule Specifications: Observed OOS results at 6-months...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Cipla USA, Inc. directly.
Affected Products
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
Quantity: 271 cartons - Ex: 84 outer cartons x 4 inner cartons x 4 blisters x 7 capsules
Why Was This Recalled?
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Cipla USA, Inc.
Cipla USA, Inc. has 15 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report