The Recall Desk
HighFDA (Drugs)·D-0040-2026·Announced 2025-10-15

Ascorbic Acid for Injection Recalled for Lack of Sterility Assurance

GenoGenix is recalling all lots of Ascorbic Acid (Vitamin C) for Injection due to lack of assurance of sterility. The product was 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 an injectable drug due to lack of assurance of sterility. Although no illnesses or injuries have been reported, this is a risk-of-harm product where injury has not yet been reported, meeting the criteria for a High severity rating.

Plain-English summary

GenoGenix, LLC is recalling all lots of Ascorbic Acid (Vitamin C) for Injection, preservative-free, in all strengths and presentations. The recall affects all lots within their expiry dates and were distributed nationwide.

The recall is due to lack of assurance of sterility. Patients who have received or may receive this injectable product should consult their healthcare provider.

Healthcare facilities and providers should immediately stop using affected lots and contact GenoGenix regarding the recall.

The recalled product

Product
Ascorbic Acid (Vitamin C) for Injection, Preservative Free, 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-assurance
  • 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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