The Recall Desk
HighFDA (Drugs)·D-0057-2026·Announced 2025-10-15

L-Carnitine for Injection Recall Due to Lack of Sterility Assurance

GenoGenix LLC is recalling all lots of L-Carnitine for Injection due to lack of assurance of sterility. The affected product was distributed nationwide in 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: FDA Class II recall without reported illnesses or injuries limits the score to 3 per the rubric. Lack of sterility assurance in an injectable product presents a significant risk of harm through potential contamination, justifying classification as High rather than Moderate.

Plain-English summary

GenoGenix LLC is recalling L-Carnitine for Injection, all strengths and presentations, due to lack of assurance of sterility. A total of 161 units have been identified in this recall.

The affected product was distributed nationwide in the United States. All lots of the product within expiry are included in the recall.

The recalled product

Product
L-Carnitine 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
  • 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

Same category