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Class II · ModerateRecall completed

Fexofenadine Hydrochloride

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

Does this affect you?
Check your lot numberLot #s: a) DNE0792A Exp. 06/31/2025; DNE1027A Exp. 08/31/2025. b) DNE0793A Exp. 06/31/2025. c) DNE0789A, DNE0790A, DNE0791A Exp. 06/2025, DNE1026A Exp. 08/31/025.
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

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

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 nameFEXOFENADINE HYDROCHLORIDE
Generic nameFEXOFENADINE HYDROCHLORIDE
Active ingredient(s)FEXOFENADINE HYDROCHLORIDE
Distributed by / forOhm Laboratories Inc., New Brunswick, NJ 08901
NDC51660-998-30
Show the full FDA record
Full product labelFexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hour, a) 30 Tablets per bottle, NDC 51660-998-30; Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Made in India, b) 45 Tablets per bottle, NDC 51316-800-45; Distributed by: CVS Pharmacy, Inc., Woonsocket, RI 02895, Made in India, c) 150 Tablets per bottle, NDC 51660-998-55, Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Made in India.
Recalling firmSUN PHARMACEUTICAL INDUSTRIES INC
DistributionNationwide in the USA
Quantity54,504 bottles
Recall initiated2024-01-18
Report date2024-01-31
Recall completed—
Recall numberD-0273-2024
ClassificationClass II
FDA statusCompleted
Origin on filePrinceton NJ United States

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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.