Pfizer Recalls Zarontin Capsules Due to Incorrect Expiration Date Labeling
Pfizer is recalling 7,686 bottles of Zarontin (ethosuximide) capsules because the expiration date on the label is incorrect.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, and the issue is a minor labeling error regarding the expiration date.
Plain-English summary
Pfizer Inc. is recalling 7,686 bottles of Zarontin (ethosuximide) 250 mg capsules, 100-count bottles. The recall involves Lot #3267079, which was distributed nationwide in the USA. The product is a prescription medication used to treat certain types of seizures.
The recall was initiated because the expiration date printed on the product label is incorrect. The label states an expiration date of 09/2021, but the correct expiration date is 09/2020. This is a labeling error that does not indicate a change in the product's physical composition or manufacturing process.
Consumers who have this specific lot of Zarontin should stop using it and contact their healthcare provider or pharmacist for guidance. The FDA has classified this recall as Class III, indicating that the use of or exposure to the product is not likely to cause adverse health consequences.
The recalled product
- Product
- ZARONTIN (ETHOSUXIMIDE)
- Brand
- ZARONTIN
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Prescription Medication
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #3267079
- Exp 09/2021
UPCs (1)
- 0300710237247
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Pfizer Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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