Lamotrigine Recalled Due to Cross-Contamination

January 13, 2020

The recalled lot of lamotrigine used to treat epilepsy and bipolar disorder is set to expire in June 2021 and was distributed between August 23 and August 30, 2019.

FDA

Taro Pharmaceuticals has announced a voluntary recall of lamotrigine 100 mg tablets in 100 count bottles from lot #331771, citing a cross-contamination with a small amount of another drug manufactured at the same facility.1

Originally approved in 1994, the drug has been approved as monotherapy as well as in combination with other drugs. In January of 2010, lamotrigine was granted approval as an add-on therapy for patients with epilepsy age 13 and older.

Taro’s lamotrigine product is packaged in white plastic bottles, comes with a screw cap closure and contains 100 tablets at 100 mg each. The cross-contamination occurred with Enalpril Maleate, a drug used for hypertension and congestive heart failure.

Small children exposed to the contaminated lamotrigine tablets could experience serious complications. Additionally, Enalpril Maleate has been shown to increase the risk of birth defects in a developing fetus, thus increasing the cause for concern for pregnant women taking lamotrigine.

Lot #331771 of lamotrigine 100 mg tablets has an expiration date of June 2021 and was distributed to wholesale distributors in the US market between August 23 and August 30, 2019. Taro Pharmaceuticals is urging consumers to stop using the product and return it to the pharmacy that dispensed it immediately.

The drug has been the subject of FDA warnings previously, including in 2009, when all anti-seizure medications including lamotrigine, were included in a safety alert concerning suicidal thoughts and behavior. A year later, the FDA issued a warning to consumers that lamotrigine can cause aseptic meningitis. The FDA also issued a warning for the drug in 2018, citing a rare but very serious reaction that excessively activates the body’s immune system.2

Most recently, lamotrigine received FDA approval in August as an adjunctive therapy for partial seizures, primary generalized tonic-clonic seizures, and generalized seizures of Lennox-Gastaut syndrome in patients 2 and older. Just 3 months later, it gained investigational new drug (IND) approval for the first-ever liquid formulation of the drug for the treatment of epilepsy and bipolar disorder.

Any adverse reactions or problems with this recalled product should be reported to the FDA’s MedWatch Adverse Event Reporting program.

REFERENCES:

1. Taro Pharmaceuticals USA, Inc issues voluntary nationwide recall of lamotrigine tablets USP, 100 mg, 100 count bottles [news release]. Hawthorne, NY: Taro Pharmaceuticals. January 10, 2020. businesswire.com/news/home/20200110005522/en/. Accessed January 13, 2020.

2. FDA warns of serious immune system reaction with seizure and mental health medicine lamotrigine (Lamictal)[news release]. FDA. April 25, 2018. fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-warns-serious-immune-system-reaction-seizure-and-mental-health. Accessed: January 13, 2020.