The Recall Desk
HighFDA (Drugs)·D-0070-2026·Announced 2025-10-15

Zinc Sulfate for Injection Recalled Nationwide Due to Sterility Concerns

GenoGenix LLC is recalling all lots of Zinc Sulfate for Injection due to lack of assurance of sterility. The affected products were distributed nationwide and may pose infection risk to patients.

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 of an injectable drug product with lack of assurance of sterility, representing a risk-of-harm scenario. No illnesses or injuries are reported in the source text.

Plain-English summary

GenoGenix LLC is recalling all lots of Zinc Sulfate for Injection in all strengths and presentations due to lack of assurance of sterility. The product has been distributed nationwide.

Zinc Sulfate for Injection is an injectable drug product. The lack of assured sterility poses a potential risk to patients who receive injections from affected lots. All lots within expiry are included in this recall.

Healthcare providers and dispensing facilities in possession of the affected product should cease distribution immediately. Patients who have received or may have received Zinc Sulfate for Injection from the recalled lots should consult their healthcare provider regarding any potential health effects or concerns.

The recalled product

Product
Zinc Sulfate 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 / Parenteral
Hazard
  • lack-of-sterility

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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