Class II · Moderate risk
Zonisamide Capsules USP
CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Is Zonisamide recalled?
Not under an active recall.
Zonisamide was recalled 13 times in the past — all now closed. Most recent: May 13, 2022.
Most common reason: cGMP deviation (9 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Zonisamide. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Zonisamide recalls on record
none so far in 2026; 13 on record, newest first
Class II · Moderate risk
Zonisamide Capsules
cGMP deviations
Class II · Moderate risk
Zonisamide Capsules
cGMP deviations
Class II · Moderate risk
Zonisamide Capsules USP
cGMP deviations
Class II · Moderate risk
Zonisamide 100 mg Capsules
CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Class II · Moderate risk
Class II · Moderate risk
Zonisamide Capsules USP 50 mg 100 Capsules Rx Only NDC…
CGMP Deviations
Class II · Moderate risk
Zonisamide capsules
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Zonisamide Capsules
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Zonisamide Capsules
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Zonisamide Capsules
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Zonisamide 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.
Class II · Moderate risk
ZONISAMIDE Capsule
Labeling: Label Mixup; ZONISAMIDE Capsule, 100 mg may be potentially mislabeled as PHYTONADIONE, Tablet, 5 mg, NDC 25010040515, Pedigree: W003737, EXP: 5/31/2014.
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