Montelukast Sodium Tablet, Chewable
FDA Recall NDC 55111-593
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 Montelukast Sodium (NDC 55111-593). A significant event, classified as Class II, was initiated on Oct 13, 2023 by Dr.reddy's Laboratories Limited. The reported reason for this action was: "Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25 mg."
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
Class II Terminated
Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25 mg.
Oct 13, 2023
Nov 15, 2023
1,656 bottles
Recall Profile & Regulatory Data
Event ID
93225
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Sep 09, 2024
Product Description
Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed by: Dr. Reddy's Laboratories., Princeton, NJ 08540, Made in India, NDC# 55111-725-10.
Batch or Lot Expiration Information
Lot# C2305569, Exp. date 03/31/2026
Affected Packages Involved in this Recall
55111-725-30Product
55111-725-90Product
55111-725-01Product
55111-725-10Product
55111-725-79Product
55111-725-78Product
55111-593-30Product
55111-593-90Product
55111-593-05Product
55111-593-79Product
55111-593-78Product
55111-594-30Product
55111-594-90Product
55111-594-05Product
55111-594-79Product
55111-594-78Product
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.
