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FDA DrugClass IIINotable

FDA Recall: Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufactured for: Cipla USA, I

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

164 cartons

View original recall →
FDA Recall: Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufactured for: Cipla USA, I | RecallWatch