The Recall Desk
HighFDA (Drugs)·D-0045-2026·Announced 2025-10-15

B6 Injection Recall: FDA Class II Alert for Sterility Concerns

FDA recalls all lots of B6 (Pyridoxine HCl) for Injections manufactured by GenoGenix LLC due to lack of sterility assurance. The injectable product is distributed nationwide.

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 injectable medication due to sterility defect. Lack of sterility in injectable drugs represents a risk-of-harm situation with potential for serious infection, and no illnesses or injuries are reported in the source text.

Plain-English summary

GenoGenix LLC is recalling all lots of B6 (Pyridoxine HCl) for Injections in all strengths and presentations. The product is also labeled as manufactured for Synergy Wellness, and has been distributed nationwide.

The FDA classified this as a Class II recall due to lack of assurance of sterility. Injectable medications without proper sterility assurance may be contaminated, presenting a potential infection risk to patients.

All lots currently within their expiration date are included in this recall.

The recalled product

Product
B6 (Pyridoxine HCl) for Injections, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Synergy Wellness
Manufacturer
GenoGenix LLC
Category
Drug — Injectable vitamin supplement
Hazard
  • sterility-defect
  • 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.

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