Pfizer Recalls Tikosyn Capsules Due to Foreign Object Contamination
Pfizer is recalling Tikosyn (dofetilide) 500 mcg capsules because a single 250 mcg capsule was found in one bottle. The recall covers 23,064 bottles distributed nationwide.
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: The recall is classified as FDA Class II, which typically involves a situation that might cause temporary or medically reversible adverse health consequences. The hazard is a foreign object (wrong dose capsule) in a single bottle, which is a low-risk contamination event without reported injuries.
Plain-English summary
Pfizer Inc. is recalling Tikosyn (dofetilide) 500 mcg (0.5 mg) capsules, 60-count bottles, NDC 00069-5820-60. The recall was initiated after a single Tikosyn (dofetilide) 250 mcg capsule was discovered in one bottle of the 500 mcg product. This constitutes a foreign object contamination issue.
The affected product includes 23,064 bottles with lot numbers H48496 and H48497, with an expiration date of 05/15. The product was distributed US Nationwide, including Puerto Rico and US Virgin Islands. Additionally, 65 federal government accounts received the affected product directly from Pfizer Inc.
Consumers and healthcare providers should check their inventory for the specific NDC, lot numbers, and expiration date listed above. If the product is found, it should be returned to the pharmacy or supplier for replacement or refund. Patients should consult their healthcare provider regarding alternative treatment options if they have been prescribed this specific medication.
The recalled product
- 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
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 23,064
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)
- H48496
- H48497
- Exp 05/15
Distribution
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