Cipla USA, Inc. recalls Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India, Ma
Recalled March 11, 2026 · FDA recall D-0381-2026 · Cipla USA
Hazard
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test. · FDA Class III
Units
271 cartons - Ex: 84 outer cartons x 4 inner cartons x 4 blisters x 7 capsules
Sold at
U.S.A. Nationwide
Description
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
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
Manufacturer(s)
Cipla USA, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →