The Recall Desk
HighFDA (Drugs)·D-0039-2026·Announced 2025-10-15

Amino Blend for Injection Recalled Due to Lack of Sterility Assurance

GenoGenix is recalling all lots of Amino Blend for Injection nationwide due to lack of assurance of sterility. Patients should consult their healthcare provider.

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 an injectable product with potential for serious harm due to lack of sterility assurance. No illnesses or injuries are reported in the source; the hazard is theoretical, warranting a High severity rating per the rubric.

Plain-English summary

GenoGenix, LLC is recalling all strengths and presentations of Amino Blend for Injection due to lack of assurance of sterility. The FDA has determined that the manufacturer cannot adequately assure that all units of this injectable product meet sterility standards required for safe use.

The affected product was distributed nationwide. All lots still within their expiration dates are included in this recall, affecting approximately 235 units.

Patients currently using or who have used this product should consult their healthcare provider immediately. Healthcare providers should not administer any affected lots of this product and should properly dispose of unexpired units according to applicable guidelines.

The recalled product

Product
Amino Blend 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 / Amino Acids
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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