The Recall Desk
HighFDA (Drugs)·D-0075-2026·Announced 2025-10-15

Elite Stack Reconstitution Solution for Injection Recalled for Sterility Assurance

GenoGenix LLC is recalling Elite Stack Reconstitution Solution for Injection nationwide due to lack of assured sterility. All unexpired lots are included in the Class II recall.

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: This recall involves a risk-of-harm product (an injectable solution without assured sterility) where injury has not been reported, meeting the rubric criterion for High severity. No illnesses or injuries have been documented.

Plain-English summary

Elite Stack Reconstitution Solution for Injection is being recalled nationwide by GenoGenix LLC due to a lack of assured sterility. The product is marketed under the GenoGenix name as well as under labels for Extension Health and Medical Health Institute (MHI), and includes all strengths and presentations.

The recall encompasses all lots of the product that are currently within their expiration dates. GenoGenix LLC, based in Boca Raton, Florida, initiated this Class II recall based on sterility assurance concerns.

For an injectable solution, sterility is essential to prevent contamination-related harm to patients.

The recalled product

Product
Elite Stack Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Extension Health and Medical Health Institute (MHI).
Manufacturer
GenoGenix LLC
Category
Drug — Injectable solution
Hazard
  • lack-of-sterility

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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