Medications & Supplements/Prescription Drugs

AVKARE Inc.: Lamotrigine Tablets Recalled for Foreign Substance Contamination

Agency Publication Date: June 4, 2020

Summary

AVKARE Inc. has recalled 4,124 bottles of Lamotrigine Tablets (150 mg), a prescription medication used to treat seizures and bipolar disorder. The recall was issued because foreign granules from desiccant packs—which are used to keep medicine dry during storage—were found inside the medication bottles. Consumers should contact their healthcare provider or pharmacist regarding this recall and for guidance on obtaining a replacement.

Risk

Ingesting the foreign granules from a desiccant pack along with the medication could cause physical irritation or internal injury to the digestive tract.

What You Should Do

Check your prescription bottle to see if it is Lamotrigine Tablets, USP, 150 mg with NDC 42291-368-60 (60-count) or NDC 42291-368-50 (500-count).
Look for lot number 25634 or lot number 25633 with an expiration date of 09/30/2021 printed on the label.
If you have an affected bottle, contact your healthcare provider or pharmacist immediately for guidance on whether to continue use and how to obtain a safe replacement.
Return any unused tablets from the recalled lots to your pharmacy for a refund and further instructions.
Contact the manufacturer, AVKARE Inc., at their Pulaski, Tennessee facility if you have additional questions regarding this product recall.
For further consumer safety 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 provider consultation and pharmacy 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, 150 mg (60 count Bottle)

Model:

NDC 42291-368-60

Lot Numbers:

25634 (Exp. 09/30/2021)

Date Ranges: Exp. 09/30/2021

Product: Lamotrigine Tablets, USP, 150 mg (500 count Bottle)

Model:

NDC 42291-368-50

Lot Numbers:

25633 (Exp. 09/30/2021)

Date Ranges: Exp. 09/30/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85783

Status: Resolved

Manufacturer: AVKARE Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 4124 bottles

Distributed To: Nationwide

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 Lamotrigine Tablets, USP, 150 mg with NDC 42291-368-60 (60-count) or NDC 42291-368-50 (500-count).

Look for lot number 25634 or lot number 25633 with an expiration date of 09/30/2021 printed on the label.

If you have an affected bottle, contact your healthcare provider or pharmacist immediately for guidance on whether to continue use and how to obtain a safe replacement.

Return any unused tablets from the recalled lots to your pharmacy for a refund and further instructions.

Contact the manufacturer, AVKARE Inc., at their Pulaski, Tennessee facility if you have additional questions regarding this product recall.

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