Class II · Moderate risk
Imatinib Mesylate Tablets 100mg
Failed Dissolution Specifications
Is Imatinib recalled?
Not under an active recall.
Imatinib was recalled 5 times in the past — all now closed. Most recent: Feb 17, 2021.
Most common reason: cGMP deviation (3 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Imatinib. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Imatinib recalls on record
none so far in 2026; 5 on record, newest first
Class II · Moderate risk
Imatinib Mesylate Tablets 400 mg
CGMP Deviations
Class II · Moderate risk
Imatinib Mesylate Tablets 100 mg
CGMP Deviations
Class II · Moderate risk
Imatinib Mesylate Tablet 400 mg NDC 60505-2901-03 30 days supply
Lack of Processing Controls.
Class II · Moderate risk
Imatinib Mesylate active pharmaceutical ingredient packaged in…
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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