Eugia Eptifibatide Injection Recall: Failed Impurities Risk
Eugia US LLC recalls Eptifibatide injection vials made in India with failed impurities that could pose health risks. Affected units have specific NDC and lot numbers.
Recall notice
Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
Contact the company
What happened, in plain English
Eugia US LLC is recalling Eptifibatide injection vials due to failed impurities that may cause health risks. This recall affects patients using the medication as prescribed by a doctor. Read more at govinfonow.com/recall/32658-eugia-eptifibatide-injection-recall-failed-impurities-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/32658-eugia-eptifibatide-injection-recall-failed-impurities-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0556-2024
Cite this page
“Eugia Eptifibatide Injection Recall: Failed Impurities Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32658-eugia-eptifibatide-injection-recall-failed-impurities-risk. Based on FDA recall #D-0556-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0556-2024%22&limit=1).
Why it’s dangerous
The injection vials contain a failed impurity identified as Eptifibatide dimer. This impurity could potentially cause health risks when administered as a medication.
Who’s affected
Patients prescribed Eptifibatide injection by a doctor are most at risk. The recall applies to specific vial lots manufactured in India.
How to tell if you have this one
Check for the NDC number 55150-219-10 and lot number 3EF22003 on the vial label. The vials were manufactured in India and expire June 30, 2025.
- Brand
Eugia- Category
Drug
What to do — step by step
Check Vial Label
Look for NDC 55150-219-10 and lot number 3EF22003 on the vial.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “USA nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 35 days after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0556-2024 (May 22, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0556-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.