Class IIOngoing

pH Buffered Reconstitution Solution for Injection recall

FDA recall D-0080-2026 · initiated Jul 30, 2025

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

Lack of Assurance of Sterility

Details

Product: pH Buffered Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Medical Health Institute (MHI), 10mL.
Recalling company: GenoGenix LLC
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: US Nationwide.
Initiated: Jul 30, 2025
FDA report date: Oct 15, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0080-2026 ↗

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