# FDA recall D-1253-2014

> **Pfizer Inc.** · Class II · drug recall initiated 2014-04-08.

## Product

Tikosyn¿  (dofetilide) 500 mcg (0.5mg) capsules, 60-count bottle, Rx only Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, NDC 00069-5820-60

## Reason for recall

Presence of Foriegn Tablets/Capsules: A single Tikosyn¿ (dofetilide) 250 mcg capsule was discovered in one bottle of Tikosyn¿ (dofetilide) 500 mcg (0.5 mg).

## Distribution

US Nationwide including Puerto Rico and US Virgin Islands. 65 federal government accounts received the affected product directly from Pfizer Inc

## Key facts

- **Recall number:** D-1253-2014
- **Recalling firm:** Pfizer Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-04-08
- **Report date:** 2014-04-30
- **Termination date:** 2017-04-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** N/A

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1253-2014

## Citation

> AI Analytics. FDA recall D-1253-2014. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-1253-2014. Source: US FDA. Licensed CC0.

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