Medications & Supplements/Prescription Drugs

EYWA PHARMA INC: Levetiracetam Tablets Recalled Due to Foreign Tablet in Bottle

Agency Publication Date: November 25, 2020

Summary

Eywa Pharma Inc. is recalling 5,451 bottles of Levetiracetam (brand name Keppra), a medication used to treat seizures. This recall was initiated after a 1000 mg Levetiracetam tablet was found inside a bottle labeled as containing 500 mg tablets. If a patient unknowingly takes a 1000 mg tablet instead of their prescribed 500 mg dose, they will receive double the intended medication, which could lead to adverse health effects. These prescription tablets were distributed nationwide in the United States.

Risk

Taking a higher dose of Levetiracetam than prescribed can cause significant side effects such as extreme drowsiness, agitation, aggression, or depressed consciousness. For patients managing epilepsy, incorrect dosing could potentially interfere with seizure control or lead to toxicity.

What You Should Do

Check your medication bottle for Levetiracetam Tablets, USP 500 mg, distributed in 120-count bottles with NDC 71930-063-52.
Verify the lot number and expiration date on the label to see if your bottle is affected: look for Lot LEV5019021A with an expiration date of 10/2021.
Inspect the tablets inside the bottle; if you find any tablets that appear larger or different from the others, do not consume them.
Contact your healthcare provider or pharmacist immediately for guidance if you believe you have taken the wrong dose or if you have an affected bottle.
Return any unused product from the affected lot to your pharmacy for a refund and contact Eywa Pharma Inc. at 1-888-723-3332 for further instructions.
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

Contact healthcare provider and return to pharmacy

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

Affected Products

Product: Levetiracetam Tablets, USP 500 mg (120-count bottle)

Model:

NDC 71930-063-52

Recall #: D-0109-2021

Lot Numbers:

LEV5019021A (Exp 10/2021)

Date Ranges: Expiration 10/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86740

Status: Resolved

Manufacturer: EYWA PHARMA INC

Sold By: Pharmacies

Manufactured In: India, United States

Units Affected: 5451 bottles

Distributed To: Nationwide

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 medication bottle for Levetiracetam Tablets, USP 500 mg, distributed in 120-count bottles with NDC 71930-063-52.

Verify the lot number and expiration date on the label to see if your bottle is affected: look for Lot LEV5019021A with an expiration date of 10/2021.

Inspect the tablets inside the bottle; if you find any tablets that appear larger or different from the others, do not consume them.

Contact your healthcare provider or pharmacist immediately for guidance if you believe you have taken the wrong dose or if you have an affected bottle.

Return any unused product from the affected lot to your pharmacy for a refund and contact Eywa Pharma Inc. at 1-888-723-3332 for further instructions.

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