Reported Nov 15, 2023 · Terminated

Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed by: Dr. Reddy's Laboratories.,…

Dr. Reddy's Laboratories, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Dr. Reddy's Laboratories, Inc. · 107 College Rd E · Princeton, NJ · 08540-6623

Is this the product you have?

  • Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle
  • Distributed byDr. Reddy's Laboratories., Princeton, NJ 08540, Made in India, NDC# 55111-725-10
Lot codes and dates
    • Lot # C2305569
    • Exp. date 03/31/2026
Amount recalled
1,656 bottles

Where it was sold

  • Nationwide

Why it was 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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Sep 9, 2024 · Data as of Sep 19, 6:38 PM UTC

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