Medications & Supplements/Prescription Drugs

Taro Pharmaceuticals U.S.A., Inc.: Lamotrigine Tablets Recalled Due to Enalapril Maleate Cross-Contamination

Agency Publication Date: February 7, 2020

Summary

Taro Pharmaceuticals has recalled one lot of Lamotrigine (Lamictal) 100 mg tablets, used to treat seizures and bipolar disorder, because they were found to be contaminated with enalapril maleate. This blood pressure medication was accidentally mixed into the lamotrigine tablets during the manufacturing process. Consumers who are currently taking this medication from the affected 100-count bottles should consult their healthcare provider or pharmacist immediately.

Risk

The presence of enalapril maleate in a product intended to be lamotrigine can cause unexpected drops in blood pressure, dizziness, and potential kidney issues, especially in pregnant women where it may cause harm to the developing fetus.

What You Should Do

Check your prescription bottle of Lamotrigine Tablets, USP, 100 mg (NDC 51672-4131-1) to see if it matches Lot #: 331771 with an expiration date of June 2021.
If you have the affected medication, do not stop taking it without first consulting your doctor or pharmacist, as stopping seizure medication abruptly can cause health risks.
Contact your healthcare provider or pharmacist immediately for guidance on obtaining a replacement and to report any side effects.
Return any unused tablets from the affected lot to the pharmacy where you purchased them for a refund.
Contact Taro Pharmaceuticals U.S.A., Inc. at their distributor office in Hawthorne, NY, or via the FDA Consumer Complaint line 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 your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

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

Affected Products

Product: Lamotrigine Tablets, USP, 100 mg, Rx Only (100-count bottle)

Model:

NDC 51672-4131-1

Recall #: D-0833-2020

Lot Numbers:

331771 (Exp. June 2021)

Date Ranges: June 2021

Product Images

Label, Lamotrigine Tablets 100mg

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 84645

Status: Resolved

Manufacturer: Taro Pharmaceuticals U.S.A., Inc.

Sold By: pharmacies

Manufactured In: Israel, United States

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 · FDA Press Release · 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 of Lamotrigine Tablets, USP, 100 mg (NDC 51672-4131-1) to see if it matches Lot #: 331771 with an expiration date of June 2021.

If you have the affected medication, do not stop taking it without first consulting your doctor or pharmacist, as stopping seizure medication abruptly can cause health risks.

Contact your healthcare provider or pharmacist immediately for guidance on obtaining a replacement and to report any side effects.

Return any unused tablets from the affected lot to the pharmacy where you purchased them for a refund.

Contact Taro Pharmaceuticals U.S.A., Inc. at their distributor office in Hawthorne, NY, or via the FDA Consumer Complaint line 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.