Recalling firm
Dr. Reddy's Laboratories, Inc.
Product type
Drug
Status
Terminated
Report date
2023-11-15
Distribution
Nationwide
Firm state
NJ
Product quantity
1,656 bottles
Initiated by
Voluntary: Firm initiated
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.
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.
Code / lot info
Lot # C2305569, Exp. date 03/31/2026
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.