Class II · Moderate risk
Ethosuximide Oral Solution USP 250 mg/5 mL
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
Is Ethosuximide recalled?
Not under an active recall.
Ethosuximide was recalled 4 times in the past — all now closed. Most recent: Jul 29, 2021.
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 Ethosuximide. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Ethosuximide recalls on record
none so far in 2026; 4 on record, newest first
Class III · Low risk
Zarontin (ethosuximide capsules, USP)
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.
Class III · Low risk
ethosuximide capsules
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.
Class II · Moderate risk
Ethosuximide Capsules
Failed Impurities/Degradation Specifications: Out of specification (OOS) results for unspecified impurity.
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