FDAClass IIIMarch 29, 2023

Dofetilide Capsules recall

Dofetilide Capsules, 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396…

Why was Dofetilide Capsules recalled?

Failed Content Uniformity Specifications

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # DND1541A, Exp 08/2024

Product
Dofetilide Capsules, 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396…
Recalling firm
SUN PHARMACEUTICAL INDUSTRIES INC
Quantity
1,920 bottles
Distribution
USA nationwide.
Recall date
March 29, 2023
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls