The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-1082-2023·Announced 2023-08-16

Dofetilide Capsules Recalled Due to Out-of-Specification Content Uniformity

Sun Pharmaceutical recalls Dofetilide 500 mcg capsules nationwide due to out-of-specification results in content uniformity testing. Affected lot DNE0217A with expiration 01/2025 may not meet pharmaceutical specifications.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class III recall with out-of-specification content uniformity testing results and no reported illnesses or deaths. Per the rubric, FDA Class III recalls are typically scored 1 or 2. The specification failure in the active pharmaceutical ingredient justifies a Moderate rating as a precautionary quality assurance recall.

Plain-English summary

Sun Pharmaceutical Industries Inc is recalling Dofetilide 500 mcg capsules, a prescription antiarrhythmic medication. The recall affects 360 60-count bottles distributed nationwide in the USA. The affected lot is DNE0217A with expiration 01/2025.

The recall was initiated due to out-of-specification results observed in content uniformity testing. This means testing found that the active ingredient content did not meet FDA specifications for uniformity across the batch.

Patients and healthcare providers who have bottles from lot DNE0217A should discontinue use and contact Sun Pharmaceutical Industries Inc (Cranbury, NJ 08512) for information about return or replacement. Patients should consult their healthcare provider before making any changes to their medication regimen.

The recalled product

Product
DOFETILIDE (DOFETILIDE)
Brand
DOFETILIDE
Manufacturer
SUN PHARMACEUTICAL INDUSTRIES INC
Category
Drug — Antiarrhythmic
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot: DNE0217A
  • Exp 01/2025

UPCs (2)

  • 0347335062861
  • 0347335061864

Distribution

Distributed nationwide across the United States.

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