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Class II · ModerateRecall completed

Febuxostat

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

Does this affect you?
Check your lot numberLot #s: DNE0867A Exp. 06/30/2025, DNE0894B Exp. 07/31/2025
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 bySun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), INDIA foreign manufacturer
Brand nameFEBUXOSTAT
Generic nameFEBUXOSTAT
Active ingredient(s)FEBUXOSTAT
Distributed by / forSun Pharmaceutical Industries, Inc., Cranbury, NJ 08512
NDC47335-722-83
Show the full FDA record
Full product labelFebuxostat Tablets 80 mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), INDIA, NDC 47335-722-83.
Recalling firmSUN PHARMACEUTICAL INDUSTRIES INC
DistributionNationwide in the USA
Quantity19,992 bottles
Recall initiated2024-01-18
Report date2024-01-31
Recall completed—
Recall numberD-0265-2024
ClassificationClass II
FDA statusCompleted
Origin on filePrinceton NJ United States

Related

Recent 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.