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Class II · ModerateRecall completed

Desloratadine

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

Does this affect you?
Check your lot numberLot # G201822, exp. date Jan 2024, 100 count G201823, exp. date Jan 2024, 100 count G201824, exp. date Jan 2024, 500 count
Where it was soldProduct was distributed nationwide.
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

CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.

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 byLupin Pharmaceuticals, Inc.
Brand nameDESLORATADINE
Generic nameDESLORATADINE
Active ingredient(s)DESLORATADINE
Distributed by / forLupin Pharmaceuticals, Inc. Baltimore, Maryland 21202
NDC68180-153-01
Show the full FDA record
Full product labelDesloratadine Tablets USP 5mg a) 100 count (NDC 68180-153-01) and b) 500 count (NDC 68180-153-02) bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202.
Recalling firmLupin Pharmaceuticals Inc.
DistributionProduct was distributed nationwide.
Quantity100=29,184 bottles; 500=2922 bottles
Recall initiated2023-12-20
Report date2024-01-17
Recall completed2025-04-04
Recall numberD-0221-2024
ClassificationClass II
FDA statusTerminated
Origin on fileBaltimore MD United States

Related

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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.