The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0383-2023·Announced 2023-03-08

Prescription Drug Dofetilide Recalled Due to Manufacturing Compliance Deviations

Accord Healthcare is recalling Dofetilide antiarrhythmic capsules due to manufacturing deviations found during an FDA inspection. The recall involves 37,790 bottles distributed across the United States, Puerto Rico, and Canada.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 II recall with no reported illnesses or injuries. The manufacturing deviations represent a compliance issue identified during inspection; per the severity rubric, precautionary recalls with theoretical rather than established hazards score as Moderate (2).

Plain-English summary

Accord Healthcare, Inc. is recalling 37,790 bottles of Dofetilide antiarrhythmic capsules (125 micrograms). Dofetilide is a prescription medication used to treat abnormal heart rhythms. The product is being recalled following an FDA inspection that identified manufacturing deviations.

The FDA's inspection of the manufacturing facilities uncovered deviations from Current Good Manufacturing Practice (CGMP) standards. These deviations affect the quality assurance and manufacturing processes used to produce this medication.

The affected product was distributed throughout the United States, including Puerto Rico and Canada. Multiple batches are included in the recall, with expiration dates ranging from February 2023 through August 2025.

Patients who have this medication should contact their healthcare provider or Accord Healthcare, Inc. for guidance. Healthcare providers and pharmacies should identify affected batches in their inventory using the provided lot numbers and NDC codes. The FDA continues to monitor this situation.

The recalled product

Product
DOFETILIDE (DOFETILIDE)
Brand
DOFETILIDE
Manufacturer
Accord Healthcare, Inc.
Category
Drug — Antiarrhythmic
Hazard
Affected units
37,790

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 (20)

  • Batches: P2101480
  • Exp. Date 2/28/2023
  • P2102579
  • P2102596
  • Exp. Date 4/30/2023
  • P2104711
  • P2104707
  • Exp. Date 6/30/2023
  • P2200771
  • P2200829
  • P2200795
  • Exp. Date 12/31/2023
  • P2202608
  • Exp. Date 4/30/2025
  • P2203492
  • P2203463
  • Exp. Date 5/31/2025
  • P2205373
  • P2205412
  • Exp. Date 8/31/2025

UPCs (1)

  • 316729490122

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 67 recalled by Accord Healthcare, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 67 products in this recall →

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