The Recall Desk
HighFDA (Drugs)·D-0073-2026·Announced 2025-10-15

EDTA for Injection Recalled Due to Sterility Assurance Defect

GenoGenix LLC is recalling all lots of EDTA for Injection nationwide due to lack of assurance of sterility, affecting all strengths and presentations.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall for a sterility assurance issue in injectable medication. No illnesses or injuries have been reported in the source material. This qualifies as a risk-of-harm product where injury has not yet been reported, meeting the rubric criterion for score 3 (High).

Plain-English summary

GenoGenix LLC is recalling all lots and presentations of EDTA for Injection nationwide due to lack of assurance of sterility. The recall encompasses all product that remains within its expiration date.

Sterility is critical for injectable medications. The manufacturer has determined that assurance of sterility cannot be provided for the affected lots. This recall applies to all strengths and presentations of EDTA for Injection.

Patients and healthcare providers who have EDTA for Injection from this recall should not use the product. Individuals currently taking this medication should consult with their healthcare provider about alternative options.

The recalled product

Product
EDTA for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Manufacturer
GenoGenix LLC
Category
Drug — Injectable Pharmaceutical
Hazard
  • lack-of-sterility
  • contamination-risk

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 (1)

  • All lots within expiry.

Distribution

Distributed nationwide across the United States.

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