The Recall Desk
HighFDA (Drugs)·D-0053-2026·Announced 2025-10-15

GenoGenix Glutathione Injection Recalled Over Sterility Concerns

GenoGenix is recalling all lots of Glutathione Preserved for Injection nationwide due to lack of assurance of sterility. Non-sterile injectable products could expose patients to serious infections.

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 Class II drug recall involves a sterility assurance failure in an injectable product. Injectable products without proper sterility present a high risk of serious infection. The product poses a risk of harm and no illnesses have been reported to date, fitting the criterion for a High-severity recall.

Plain-English summary

GenoGenix LLC is recalling all lots and strengths of Glutathione Preserved for Injection distributed nationwide in the United States. The recall is due to a lack of assurance of sterility.

Glutathione for injection is administered directly into the body. If the product is not properly sterilized, it could potentially introduce bacteria or other microorganisms that could cause serious infections in patients.

The product has been distributed nationwide. Healthcare providers and patients who have received this product should consult their healthcare provider about the recall. No illnesses have been reported in connection with this recall.

Patients should not discontinue treatment without consulting their healthcare provider, as any medical decisions must account for their individual health needs. Persons with questions may contact GenoGenix LLC at 2840 NW 2nd Ave Ste 204, Boca Raton, FL 33431-6692.

The recalled product

Product
Glutathione Preserved 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
Hazard
  • sterility-failure
  • contamination-risk
  • injection-safety

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

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