PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: November 15, 2023 Initiated: October 13, 2023 #D-0086-2024

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.

Reason for Recall

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.

Details

Units Affected
1,656 bottles
Distribution
Nationwide
Location
Princeton, NJ

Frequently Asked Questions

What product was recalled?
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.. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: 1,656 bottles.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 15, 2023. Severity: Moderate. Recall number: D-0086-2024.