Lamotrigine Tablet
FDA Recall NDC 51672-4133
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Lamotrigine (NDC 51672-4133). A significant event, classified as Class I, was initiated on Dec 20, 2019 by Sun Pharmaceutical Industries, Inc.. The reported reason for this action was: "Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
December 2019 Class I Recall: Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.
Recall Number
Class I Terminated
Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.
Dec 20, 2019
Feb 19, 2020
N/A
Recall Profile & Regulatory Data
Event ID
84645
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Taro Pharmaceuticals U.S.A., Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the U.S. and Puerto Rico.
Termination Date
Feb 23, 2024
Product Description
Lamotrigine Tablets, USP, 100 mg, Rx Only, 100-count bottle, Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4131-1.
Batch or Lot Expiration Information
Lot# : 331771, Exp. June 2021
Affected Packages Involved in this Recall
51672-4130-6Product
51672-4130-4Product
51672-4130-1Product
51672-4130-3Product
51672-4130-0Product
51672-4131-6Product
51672-4131-4Product
51672-4131-1Product
51672-4131-3Product
51672-4131-0Product
51672-4132-6Product
51672-4132-4Product
51672-4132-1Product
51672-4132-2Product
51672-4132-3Product
51672-4132-0Product
51672-4133-6Product
51672-4133-4Product
51672-4133-1Product
51672-4133-2Product
51672-4133-3Product
51672-4133-0Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
