Pfizer Recalls Tikosyn Capsules Due to Potential Cracks or Breakage
Pfizer is recalling Tikosyn (dofetilide) capsules because they may be cracked or broken. The recall affects 31,569 bottles shipped to 4,447 direct accounts.
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: The recall is classified as FDA Class II, which typically involves a temporary or medically reversible adverse health consequence. The hazard is physical (cracked/broken capsules) rather than a high-risk pathogen or structural vehicle defect, fitting the Moderate criteria for low-risk contamination or minor defects.
Plain-English summary
Pfizer Inc. is recalling Tikosyn (dofetilide) 125 mcg capsules due to the potential presence of cracked or broken capsules. The affected product is a prescription-only medication manufactured by Pfizer Labs, Division of Pfizer, Inc. The recall involves 31,569 HDPE bottles in 14-count and 60-count sizes.
The specific lots affected are H79652 and H79653, both with an expiration date of 10/15. Pfizer shipped the affected product to 4,447 direct accounts. The source text notes that no federal government accounts received the affected product directly from Pfizer Inc.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recalled description, it should be returned to the pharmacy or point of purchase for disposal or replacement according to standard recall procedures.
The recalled product
- Product
- TIKOSYN (DOFETILIDE)
- Brand
- TIKOSYN
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 31,569
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 (3)
- Lot # a) H79652
- Exp. 10/15
- b) H79653
UPCs (3)
- 0300695810602
- 0300695800603
- 0300695820601
Distribution
Distribution scope not specified by the agency.
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