Class III · Low risk
Nilotinib Capsules
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Is Nilotinib recalled?
Yes — there is an active recall. 2 ongoing FDA recalls mention Nilotinib (3 total). Check the affected lots below.
Most common reason: Failed specification (2 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Nilotinib. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Nilotinib recalls in 2026
2 initiated in 2026, 3 in total — newest first
Class III · Low risk
Nilotinib Capsules
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Class II · Moderate risk
Nilotinib active pharmaceutical ingredient packaged in varying…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
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