The Recall Desk
HighFDA (Drugs)·D-0063-2026·Announced 2025-10-15

Methylene Blue for Injection Recalled Due to Lack of Sterility Assurance

GenoGenix LLC is recalling all lots of Methylene Blue for Injection nationwide due to a lack of assurance of sterility. Consumers should not use the affected product.

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 FDA Class II drug recall involves lack of sterility assurance in an injectable product—a risk-of-harm situation with no reported illnesses or injuries in the source. Per the rubric, this fits the High (3) criterion: theoretical risk without reported injury.

Plain-English summary

GenoGenix LLC is recalling all lots of Methylene Blue for Injection in all strengths and presentations. The recall was issued due to a lack of assurance of sterility.

The affected product was distributed nationwide throughout the United States. All lots currently within their expiration dates are included in this recall. The manufacturer is GenoGenix LLC, located at 2840 NW 2nd Ave Ste 204, Boca Raton, FL 33431-6692.

Healthcare providers and consumers who have received this product should discontinue use. Those with questions about the recall should contact their healthcare provider.

The recalled product

Product
Methylene Blue 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
  • lack-of-sterility-assurance
  • infection-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

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