Reconstitution XO Solution for Injection recall
FDA recall D-0081-2026 · initiated Jul 30, 2025
GenoGenix LLC recalled Reconstitution XO Solution for Injection in Jul 2025 — an FDA Class II recall (D-0081-2026) because Lack of Assurance of Sterility.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of Assurance of Sterility
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Details
- Product
- Reconstitution XO 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 CELIA Health a) 5% Exosomes, 10 mL vial and b) 10% Exosomes, 5 mL vial, Extension Health a) 20% Exosomes, 10 mL vial, b) 10% Exosomes, 10 mL vial and Medical Health Institute (MHI), a) 10 % Exosomes, 2mL vial, 5mL vial, 10mL vial, b) 5% Exosomes, 2mL vial, 5mL vial, 10mL vial.
- 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
Frequently asked
- Was Reconstitution XO Solution for Injection recalled?
- GenoGenix LLC recalled Reconstitution XO Solution for Injection in Jul 2025 — an FDA Class II recall (D-0081-2026) because Lack of Assurance of Sterility. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Reconstitution XO Solution for Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0081-2026 was: Lack of Assurance of Sterility
- Is a recalled Reconstitution XO Solution for Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Reconstitution XO Solution for Injection are affected?
- Distributed: US Nationwide.. The recall covers these lots — All lots within expiry.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0081-2026.