The Recall Desk
HighFDA (Drugs)·D-0078-2026·Announced 2025-10-15

Pentosan for Injection recalled due to sterility assurance failure

GenoGenix is recalling all unexpired lots of Pentosan for Injection due to lack of assurance of sterility. The affected product has been distributed nationwide throughout the United States.

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 is an FDA Class II recall of an injectable drug due to lack of sterility assurance. No illnesses or injuries have been reported, but as a risk-of-harm product where injury has not yet been reported, this qualifies for a score of 3 per the rubric.

Plain-English summary

GenoGenix, LLC is recalling all unexpired lots of Pentosan for Injection in all strengths and presentations. The product was distributed nationwide throughout the United States.

The recall is due to lack of assurance of sterility, meaning the manufacturer cannot confirm that the injectable drug meets required sterility standards. This assurance is critical for the safety of injectable medications.

Patients who have received this medication should consult with their healthcare provider regarding this recall to discuss the next steps and alternative treatment options.

The recalled product

Product
Pentosan 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
  • contamination

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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