Pfizer Recalls Ethosuximide Capsules Due to Incorrect Expiration Date Labeling
Pfizer is recalling 7,824 bottles of 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 indicates the product is not likely to cause adverse health consequences. The issue is a documentation/labeling error regarding the expiration date.
Plain-English summary
Pfizer Inc. is recalling 7,824 100-count bottles of ethosuximide capsules, USP, 250 mg. The product is distributed by Greenstone LLC and was manufactured in the Netherlands. The recall involves Lot #3267079A, which was distributed nationwide in the USA.
The recall was initiated due to a labeling error where the expiration date on the product label is incorrect. The label states an expiration date of 09/2021, but the correct date is 09/2020.
Consumers who have this product should check the lot number and expiration date on the label. If the product matches the recalled lot, they should stop using it and contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- ethosuximide capsules, USP, 250 mg, 100-count bottle, Rx Only, Distributed by: Greenstone LLC Peapack, NJ 07977 Made in Netherlands. NDC 59762-2250-2
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Anticonvulsant
- 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 #3267079A
- Exp 09/2021
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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