Drug Safety Alerts

Taro Pharmaceuticals Lamotrigine Tablets Consumer-Level Recall

1/10/2020

On January 10, 2020, the United States Food and Drug Administration (FDA) published a notice regarding a consumer-level recall of Lamotrigine 100 mg tablets NDC # 51672-4131-01 manufactured by Taro Pharmaceuticals. This recall was issued because an investigation determined that this specific lot was inadvertently cross-contaminated with a small quantity of another drug used to make a different product at the same facility.

This recall affects lot number 331771 exp. 06/21.

This could be a health hazard or safety risk to patients who may be using product affected by this recall.

Risk Statement: Use of Lamotrigine 100 mg Tablets could potentially result in exposure to a small amount of Enalapril Maleate, if present in the product in question. Enalapril Maleate is a drug substance indicated for hypertension and congestive heart failure. 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, Lot # 331771 (expiration date June 2021).

Taro reports that it has not received any product complaints or adverse events related to contamination of this product with Enalapril, or any complaints or adverse events that are associated specifically with this recall.

Taro Pharmaceuticals advises that consumers should stop using this product. Patients using affected product have been advised to communicate with their healthcare provider.

Lamotrigine 100 mg tablets, Lot # 331771 were distributed to wholesale distributors in the US market between August 23 and August 30, 2019. These wholesale customers may have further distributed Lot # 331771 to retail pharmacies for prescription dispensing to patients who were prescribed 100 mg Lamotrigine Tablets.

CVS Caremark Response: Because of this action, CVS Caremark Mail Service Pharmacy is contacting patients to advise them of this recall. We are also contacting their prescribers.

For more information regarding this recall, please contact Taro Pharmaceuticals at 1-866-923-4914, Monday through Friday, 7:00 am to 7:00 pm (CT) or visit https://taro.gcs-web.com. You may also contact the FDA at 1‑888‑INFO-FDA (1‑888-463-6332) or visit https://www.fda.gov.