The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0385-2023·Announced 2023-03-08

FDA Recalls Dofetilide Antiarrhythmic Drug for Manufacturing Deviations

Accord Healthcare is recalling Dofetilide antiarrhythmic capsules due to manufacturing compliance deviations identified during FDA inspection. The recall affects approximately 113,003 bottles distributed in the U.S., 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 without reported illnesses or injuries and no specific identified safety hazard. Manufacturing compliance deviations are treated as precautionary, warranting Moderate severity.

Plain-English summary

Accord Healthcare, Inc. is recalling Dofetilide 500 mcg antiarrhythmic capsules distributed in the United States, Puerto Rico, and Canada. Approximately 113,003 bottles of the affected product have been distributed. The recall was initiated following an FDA inspection that identified manufacturing practice deviations at the producing facility. Affected batches have expiration dates ranging from February 2023 through May 2025. Patients currently taking Dofetilide should contact their healthcare provider to discuss their prescription and available treatment alternatives.

The recalled product

Product
DOFETILIDE (DOFETILIDE)
Brand
DOFETILIDE
Manufacturer
Accord Healthcare, Inc.
Category
Drug — Prescription Antiarrhythmic
Hazard
Affected units
113,003

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: P2101582
  • P2101661
  • P2101482
  • P2101686
  • Exp. Date 2/28/2023
  • P2102581
  • P2102598
  • Exp. Date 4/30/2023
  • P2103623
  • P2103653
  • P2103670
  • Exp. Date 5/31/2023
  • P2104463
  • P2104385
  • P2104386
  • P2104472
  • P2104709
  • P2104714
  • Exp. Date 6/30/2023
  • P2200797

UPCs (1)

  • 316729492126

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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