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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 #: MON17355, Exp 12/19
Where it was soldNationwide in the USA
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

Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.

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 byCamber Pharmaceuticals, Inc.
Brand nameMONTELUKAST SODIUM
Generic nameMONTELUKAST SODIUM
Active ingredient(s)MONTELUKAST SODIUM
Distributed by / forCamber Pharmaceuticals, Inc., Piscataway, NJ 08854
NDC31722-726-30
Show the full FDA record
Full product labelMontelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, NDC 31722-726-30.
Recalling firmHetero Labs Limited Unit V
DistributionNationwide in the USA
Quantity98,016 bottles
Recall initiated2018-08-20
Report date2018-10-03
Recall completed2021-11-05
Recall numberD-1213-2018
ClassificationClass II
FDA statusTerminated
Origin on fileJadcherla Mandal, Mahaboob Nagar India

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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.