The Recall Desk
HighFDA (Drugs)·D-0064-2026·Announced 2025-10-15

Injectable N-Acetyl-L-Cysteine Recalled Due to Sterility Assurance Failure

GenoGenix, LLC is recalling all lots of N-Acetyl-L-Cysteine for Injection due to lack of assurance of sterility. All strengths and presentations distributed nationwide in the U.S. are affected.

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 without reported illnesses or injuries. The lack of sterility assurance for injectable products poses significant risk of harm through potential bacterial contamination and serious infections, fitting the criterion of 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

N-Acetyl-L-Cysteine for Injection in all strengths and presentations manufactured by GenoGenix, LLC is being recalled nationwide.

The recall was initiated due to lack of assurance of sterility. For injectable medications, maintaining sterile conditions is essential to prevent serious harm to patients.

All lots of the product currently within expiry are included in the recall across the United States. Healthcare providers and patients with this medication should discontinue use and contact their healthcare provider for guidance on returning or disposing of the product safely.

The recalled product

Product
N-Acetyl-L-Cysteine 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 Medication
Hazard
  • lack-of-sterility
  • 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

Same category