CLASS I Drug recall · Reported 19 Jul 2017 · FDA Enforcement Report
EliquisTablets 5mg recalled by Bristol-myers Squibb
Bristol-myers Squibb is recalling EliquisTablets 5mg, distributed nationwide in the US. The recall was initiated on 5 Jun 2017 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0959-2017
- FDA event ID
- 77414
- Recalling firm
- Bristol-myers Squibb, New Brunswick, NJ
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 5 Jun 2017
- FDA classified
- 11 Jul 2017
- Reported
- 19 Jul 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
Timeline
| 5 Jun 2017 | Recall initiated by company | |
| 11 Jul 2017 | Classified by FDA | +36 days |
| 19 Jul 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Label Mix-up: One bottle of Eliquis 5 mg tablet was found to contain lower-strength Eliquis 2.5 mg tablets only instead of the labeled 5 mg tablets.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the US
Questions about this recall
Why was it recalled?
Labeling: Label Mix-up: One bottle of Eliquis 5 mg tablet was found to contain lower-strength Eliquis 2.5 mg tablets only instead of the labeled 5 mg tablets.
Which lots are affected?
Lot: HN0063, EXP. 09/2019
Where was it sold?
Nationwide in the US
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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