The Recall Desk
SevereFDA (Drugs)·D-0959-2017·Announced 2017-07-19

Bristol-Myers Squibb Recalls Eliquis 5mg Tablets Due to Labeling Error

Bristol-Myers Squibb is recalling 48,180 bottles of Eliquis 5mg tablets because one bottle was found to contain 2.5mg tablets instead.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class I, which per the rubric mandates a minimum score of 4 (Severe).

Plain-English summary

Bristol-Myers Squibb Company is recalling 48,180 bottles of Eliquis 5mg tablets, 60-count bottles, NDC 0003-0894-21. The recall is due to a labeling error where one bottle was found to contain lower-strength Eliquis 2.5mg tablets instead of the labeled 5mg tablets.

The affected product is identified by Lot HN0063 with an expiration date of 09/2019. The product was distributed nationwide in the US.

Consumers should check their medication for this specific lot number and expiration date. If they have the affected product, they should stop using it and contact their healthcare provider or pharmacist for guidance.

The recalled product

Product
EliquisTablets 5mg, 60 count bottle, Rx Only, Marketed by: Bristol-Meyers Squibb Company Princeton, NJ 08543 USA and Pfizer Inc. New York, NY 10017 USA, NDC 0003-0894-21
Affected units
48,180

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 (2)

  • Lot: HN0063
  • EXP. 09/2019

Distribution

Distributed nationwide across the United States.