Montelukast Sodium: 6 recalls on record

Recalled by 1 agency: FDA (6).

First recall on record: April 5, 2017. Most recent: November 15, 2023.

Risk classification: Class I: 1 · Class II: 3 · Class III: 2

Most recent recalls

DateAgencyProduct
November 15, 2023FDAMontelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed by: Dr. Re…D-0086-2024
March 8, 2023FDAMontelukast Sodium Tablets, USP, 10 mg* Rx Only, Packaged as: a) 30-count bottle NDC 1672…D-0400-2023
February 5, 2020FDAMontelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufactured for : …D-0823-2020
October 3, 2018FDAMontelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, Hetero Labs L…D-1213-2018
October 3, 2018FDAMontelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero Labs Limite…D-0081-2019
April 5, 2017FDAMontelukast sodium tablets, 10 mg, 30-count bottle, Rx Only, Manufactured for: Camber Pha…D-0623-2017

Questions about this brand

How many recalls does Montelukast Sodium have?
Recalert has 6 U.S. recalls on record for Montelukast Sodium, published between April 5, 2017 and November 15, 2023.
What was the most recent Montelukast Sodium recall?
FDA recall D-0086-2024, published November 15, 2023: 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.
Which agencies have recalled Montelukast Sodium products?
Montelukast Sodium products appear in recalls from: FDA (6).

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