FDA DrugClass IIINotable

FDA Recall: Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., V

Name: FDA Recall: Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., V
Brand: Cipla USA, Inc.

Date: 2026-03-11

Brand: Cipla USA, Inc.

Category: Drug

FDA Class: Class III

Description

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

Hazard

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

Remedy

271 cartons - Ex: 84 outer cartons x 4 inner cartons x 4 blisters x 7 capsules

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