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Class III · Lower riskRecall completed

Montelukast Sodium

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot #: BMD8901B, Exp. Date 02/2021
Where it was soldNationwide within the United States
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

Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product

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 byMacleods Pharmaceuticals Ltd Baddi, Himachal Pradesh, India foreign manufacturer
Brand nameMONTELUKAST SODIUM
Generic nameMONTELUKAST SODIUM
Active ingredient(s)MONTELUKAST
Distributed by / forMacleods Pharma USA, Inc. Plainsboro, NJ
NDC33342-111-10
Show the full FDA record
Full product labelMontelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufactured for : Macleods Pharma USA, Inc. Plainsboro, NJ Manufactured by: Macleods Pharmaceuticals Ltd Baddi, Himachal Pradesh, India NDC 33342-111-10
Recalling firmMacleods Pharma Usa Inc
DistributionNationwide within the United States
Quantity10680 units
Recall initiated2020-01-20
Report date2020-02-05
Recall completed2021-04-26
Recall numberD-0823-2020
ClassificationClass III
FDA statusTerminated
Origin on filePlainsboro 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.