FDA Drug Recalls

Recalls / Class II

Class IID-0070-2026

Product

Zinc Sulfate for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

Affected lot / code info
All lots within expiry.

Why it was recalled

Lack of Assurance of Sterility

Recalling firm

Firm
GenoGenix LLC
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
2840 Nw 2nd Ave Ste 204, Boca Raton, Florida 33431-6692

Distribution

Quantity
467
Distribution pattern
US Nationwide.

Timeline

Recall initiated
2025-07-30
FDA classified
2025-10-21
Posted by FDA
2025-10-15
Status
Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0070-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.