Class II · Moderate risk
Sunitinib Malate Capsules
Labeling: Label Mix-Up
Is Sunitinib recalled?
Yes — there is an active recall. 2 ongoing FDA recalls mention Sunitinib (3 total). Check the affected lots below.
Most common reason: Labeling / mix-up (2 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Sunitinib. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Sunitinib recalls on record
none so far in 2026; 3 on record, newest first
Class II · Moderate risk
Sunitinib Malate Capsules
Labeling: Label Mix-Up
Class II · Moderate risk
Sunitinib Malate Capsules
Failed Moisture Limits: Water (moisture) content above the approved product specifications.
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