October 2023 FDA Recall Montelukast Sodium by Dr. Reddy's Laboratories, Inc.
D-0086-2024 - Presence of Foreign Tablet(s/Capsule(s
This Class II drug recall was voluntarily initiated by Dr. Reddy's Laboratories, Inc. on October 13, 2023 for the product Montelukast Sodium. The FDA reported the reason for recall as presence of foreign tablet(s)/capsule(s). The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0086-2024
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.
10-13-2023
11-15-2023
1,656 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
09-09-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
