January 10, 2020
Taro Pharmaceuticals has announced the voluntary recall of one lot of Lamotrigine 100mg Tablets. Tablets in lot number 331771 (expiration date June 2021) have been found to be cross contaminated with another drug substance, enalapril maleate, used to manufacture a different product at the same facility.
Lamotrigine is indicated to treat epilepsy and bipolar disorder, while enalapril maleate is indicated to treat hypertension and congestive heart failure. Taking the recalled lamotrigine tablets could result in chronic exposure to enalapril maleate, which could present a risk to patients, particularly children and pregnant women. The use of enalapril maleate is associated with birth defects in a developing fetus.
As of the date of the recall, Taro Pharmaceuticals has not received any reports of adverse events related to the affected product. Consumers who have the recalled tablets in their possession should discontinue use and return the product to the place of purchase. For help with questions regarding the recall, consumers can contact Taro Pharmaceuticals at 1-866-923-4914 or TaroPVUS@taro.com. If a patient has experienced an adverse event that may be related to use of the recalled lamotrigine, they should contact their healthcare provider. Adverse events can also be reported the U.S. FDA’s MedWatch program.
Further recall details can be found online at the FDA’s website. Benecard Central Fill did not distribute any of the recalled product.