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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Pfizer Inc.: Ethosuximide Capsules and Zarontin Recalled for Incorrect Expiration Date

Agency Publication Date: September 24, 2019
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Summary

Pfizer Inc. is recalling 15,510 bottles of ethosuximide capsules and Zarontin (ethosuximide) 250 mg capsules because the labels show an incorrect expiration date of 09/2021 when the correct date is 09/2020. This recall affects 100-count bottles of both the generic version and the brand-name Zarontin, which are prescription medications used to treat seizures. Consumers using these products might mistakenly use the medication past its intended shelf life, which could lead to reduced effectiveness of the drug.

Risk

The incorrect expiration date allows the medication to be used for one year longer than it has been proven stable, which may lead to the drug losing potency and failing to adequately control seizure activity.

What You Should Do

  1. Check your medication bottles for ethosuximide capsules (250 mg) or Zarontin (250 mg) in 100-count bottles with an expiration date of 09/2021.
  2. Verify the Lot Numbers and NDCs on your packaging: look for generic ethosuximide Lot 3267079A (NDC 59762-2250-2) or Zarontin Lot 3267079 (NDC 0071-0237-24).
  3. Contact your healthcare provider or pharmacist immediately for guidance if you find your medication is part of this recall, especially if you have been taking it near or after September 2020.
  4. Return any unused bottles from these specific lots to your pharmacy to receive a refund.
  5. Contact Pfizer Inc. at 1-888-723-3332 for further instructions regarding the return process and any technical questions.
  6. For additional information or to report any adverse events, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Pharmacy return and refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: ethosuximide capsules, USP, 250 mg, 100-count bottle
Model:
NDC 59762-2250-2
Lot Numbers:
3267079A (Exp 09/2021)
Date Ranges: 09/2021 (Incorrect Expiry)
Product: Zarontin (ethosuximide capsules, USP) 250 mg, 100-count bottle
Model:
NDC 0071-0237-24
Lot Numbers:
3267079 (Exp 09/2021)
Date Ranges: 09/2021 (Incorrect Expiry)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83788
Status: Resolved
Manufacturer: Pfizer Inc.
Sold By: Pharmacies
Manufactured In: Netherlands, United States
Units Affected: 2 products (7,824 100-count bottles; 7,686 100-count bottles)
Distributed To: Nationwide
Agency Last Updated: October 1, 2019

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.