The Recall Desk
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.

What this means for you

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
  • manufacturing-deviation

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

Distribution scope not specified by the agency.

Related recalls

Same brand · DOFETILIDE

Same category