Class I Recall Issued for Anticonvulsant

Taro Pharmaceuticals USA Inc. is recalling a single lot of 100-mg lamotrigine tablets in 100-count bottles (NDC 51672-4131-1) because of cross-contamination with the drug enalapril maleate, which was manufactured at the same facility. According to the February 19, 2020, US Food and Drug Administration (FDA) Enforcement Report, the FDA has designated the recall Class I, signaling use of affected tablets could cause serious adverse health consequences. 

“Enalapril maleate is a drug substance indicated for hypertension and congestive heart failure,” Taro Pharmaceuticals stated in a news release. “There is potential with chronic exposure to enalapril maleate to impact users particularly if they are small children or pregnant women. Enalapril maleate is also associated with risk of birth defects in a developing fetus. Therefore, there is risk associated with the continued, long-term use of lamotrigine 100-mg tablets [from] lot 331771 (Exp. June 2021).” 

Lamotrigine tablets from lot 331771 were sent to wholesale distributors in the United States and Puerto Rico in August 2019. Those wholesale customers may have further distributed the now-recalled tablets to retail pharmacies for dispensing to patients. 

Taro Pharmaceuticals voluntarily initiated the recall December 20, 2019. The FDA designated the recall Class I on February 7, 2020.  

Lamotrigine is a prescription anticonvulsant indicated for the treatment of epilepsy and bipolar disorder.

—Jolynn Tumolo