Medications & Supplements/Prescription Drugs

Akorn, Inc.: Ethosuximide Capsules Recalled Due to Failed Impurity Specifications

Agency Publication Date: September 6, 2018

Summary

Akorn, Inc. is recalling 23,788 bottles of Ethosuximide Capsules (250 mg), a prescription medication used to treat seizures. The recall was initiated because the product failed quality testing, showing results for an unspecified impurity that was outside of the required safety and degradation specifications. These capsules were distributed nationwide in 100-count bottles under the VersaPharm brand name.

Risk

The presence of unspecified impurities means the medication may contain substances that have not been validated for safety, potentially reducing the drug's effectiveness or causing unexpected side effects for patients relying on it for seizure control.

What You Should Do

Check your prescription bottle to see if it is Ethosuximide Capsules, USP, 250 mg (100-count bottle) with NDC 61748-025-01.
Locate the lot number and expiration date on the side of the label to see if your bottle matches lot numbers 1165280100 or 1165280101 with an expiration date of 3/2019.
If your medication is part of this recall, contact your healthcare provider or pharmacist immediately for guidance on obtaining a replacement and do not stop taking your medication until you have a replacement supply.
Return any unused portions of the affected medication to the pharmacy where it was purchased for a refund.
Contact the manufacturer, Akorn, Inc., for further instructions regarding this recall.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare consultation 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: 61748-025-01

Recall #: D-1183-2018

Lot Numbers:

1165280100

1165280101

Date Ranges: EXP 3/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80880

Status: Resolved

Manufacturer: Akorn, Inc.

Sold By: VersaPharm Incorporated

Manufactured In: Switzerland, United States

Units Affected: 23,788 100-count bottles

Distributed To: Nationwide

Agency Last Updated: September 7, 2018

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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 · 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.

Summary

What You Should Do

Check your prescription bottle to see if it is Ethosuximide Capsules, USP, 250 mg (100-count bottle) with NDC 61748-025-01.

Locate the lot number and expiration date on the side of the label to see if your bottle matches lot numbers 1165280100 or 1165280101 with an expiration date of 3/2019.

If your medication is part of this recall, contact your healthcare provider or pharmacist immediately for guidance on obtaining a replacement and do not stop taking your medication until you have a replacement supply.

Return any unused portions of the affected medication to the pharmacy where it was purchased for a refund.

Contact the manufacturer, Akorn, Inc., for further instructions regarding this recall.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.