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Class II · ModerateRecall completed

Montelukast Sodium

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot # C2305569, Exp. date 03/31/2026
Where it was soldNationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byMade in India foreign manufacturer
Brand nameMONTELUKAST SODIUM
Generic nameMONTELUKAST SODIUM
Active ingredient(s)MONTELUKAST SODIUM
Distributed by / forDr. Reddy's Laboratories., Princeton, NJ 08540
NDC55111-725-10
Show the full FDA record
Full product labelMontelukast 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.
Recalling firmDr. Reddy's Laboratories, Inc.
DistributionNationwide
Quantity1,656 bottles
Recall initiated2023-10-13
Report date2023-11-15
Recall completed2024-09-09
Recall numberD-0086-2024
ClassificationClass II
FDA statusTerminated
Origin on filePrinceton NJ United States

Related

Montelukast recallsRecent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.