The Recall Desk
HighFDA (Drugs)·D-0054-2026·Announced 2025-10-15

GenoGenix Glycine for Injection Recalled for Lack of Sterility Assurance

GenoGenix LLC is recalling all strengths of Glycine for Injection distributed nationwide due to lack of assurance of sterility. No illnesses have been reported.

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 of an injectable drug where sterility assurance is compromised. No illnesses or injuries have been reported. Per the rubric, theoretical hazards affecting high-risk products without reported harm score at most 3.

Plain-English summary

GenoGenix LLC is recalling all strengths and presentations of Glycine for Injection distributed in the United States due to lack of assurance of sterility.

Sterility is a critical safety requirement for injectable pharmaceutical products. The recall affects all lot numbers currently within expiry distributed nationwide by GenoGenix LLC of Boca Raton, Florida.

Healthcare providers and patients who have received or are using this product should contact their healthcare provider or pharmacy for guidance. Consumers should not discontinue any prescribed medication without speaking to their healthcare provider first.

The recalled product

Product
Glycine 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.

Related recalls

Same category