Class II · Moderate risk
Clozapine Tablets USP tablet
Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg.
Is Clozapine recalled?
Not under an active recall.
Clozapine was recalled 5 times in the past — all now closed. Most recent: Jun 12, 2020.
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 Clozapine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Clozapine recalls on record
none so far in 2026; 5 on record, newest first
Class II · Moderate risk
Clozapine Orally Disintegrating Tablets
Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.
Class II · Moderate risk
Clozapine Tablets USP
Failed Tablet/Capsule Specifications; potential presence of broken tablets.
Class II · Moderate risk
Clozapine Tablets USP
Microbial Contamination of Non-Sterile Products
Class II · Moderate risk
Clozapine 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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