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Class III · Lower riskRecall completed

Dofetilide

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

Does this affect you?
Check your lot numberLot: DNE0217A, Exp 01/2025
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

Out of Specification result observed in content uniformity testing

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 Limited, Survey No. 259/15, Dadra-396 191, (U.T of D & NH), India, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 foreign manufacturer
Brand nameDOFETILIDE
Generic nameDOFETILIDE
Active ingredient(s)DOFETILIDE
Distributed by / forSun Pharmaceutical Industries, Inc. Cranbury, NJ 08512
NDC47335-063-86
Show the full FDA record
Full product labelDofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured by Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T of D & NH), India, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512. NDC 47335-063-86
Recalling firmSUN PHARMACEUTICAL INDUSTRIES INC
DistributionNationwide in the USA
Quantity360 60-count bottles
Recall initiated2023-07-18
Report date2023-08-16
Recall completed2024-02-26
Recall numberD-1082-2023
ClassificationClass III
FDA statusTerminated
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.