CLASS II ONGOING Drug recall · Reported 15 Oct 2025 · FDA Enforcement Report

Reconstitution XO Solution for Injection, all strengths recalled

GenoGenix is recalling Reconstitution XO Solution for Injection, all strengths and presentations, GenoGenix, LLC, distributed nationwide in the US. The recall was initiated on 30 Jul 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots within expiry.

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number
D-0081-2026
FDA event ID
97369
Recalling firm
GenoGenix, Boca Raton, FL
Classification
Class II
Status
Ongoing
Recall initiated
30 Jul 2025
FDA classified
21 Oct 2025
Reported
15 Oct 2025
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Sterility

Timeline

30 Jul 2025Recall initiated by company
15 Oct 2025Published in enforcement report+77 days
21 Oct 2025Classified by FDA+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Lack of Assurance of Sterility

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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.

Where it was distributed

US Nationwide.

Nationwide

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility

Which lots are affected?

All lots within expiry.

Where was it sold?

US Nationwide.

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

56 other products · FDA event 97369
ReportedClassRecallCompanyReasonWhere
CLASS IIGlycine for Injection, all strengths and presentations recalledGenoGenixSterilityNationwide
CLASS IIGHK-Cu (Copper Peptide) for Injection, all strengths recalledGenoGenixSterilityNationwide
CLASS IIMagnesium Chloride for Injection, all strengths recalled by GenoGenixGenoGenixSterilityNationwide
CLASS IICerebrolysin for Injection, all strengths and presentations recalledGenoGenixSterilityNationwide
CLASS IIL-Carnitine for Injection, all strengths and presentations recalledGenoGenixSterilityNationwide
CLASS IIN-Acetyl-L-Cysteine for Injection, all strengths recalled by GenoGenixGenoGenixSterilityNationwide
CLASS IINAD+ (Nicotinamide adenine dinucleotide), a) 50 mg/mL recalledGenoGenixSterilityNationwide
CLASS IIMethylene Blue for Injection, all strengths recalled by GenoGenixGenoGenixSterilityNationwide
CLASS IILysine for Injection, all strengths and presentations recalledGenoGenixSterilityNationwide
CLASS IIBiotin for Injection, all strengths and presentations recalledGenoGenixSterilityNationwide
CLASS IICalcium Chloride for Injection, all strengths recalled by GenoGenixGenoGenixSterilityNationwide
CLASS IIAmino Blend for Injection, all strengths and presentations recalledGenoGenixSterilityNationwide
CLASS IITesamorelin for Injection, 15mg Multi-Dose Vial, GenoGenix recalledGenoGenixSterilityNationwide
CLASS IITirzepatide, 60mg/ for Injection vial lyophilized recalled by GenoGenixGenoGenixSterilityNationwide
CLASS IIBacteriostatic Water for Injection, all strengths recalled by GenoGenixGenoGenixSterilityNationwide
CLASS IITaurine for Injection, all strengths and presentations recalledGenoGenixSterilityNationwide
CLASS IIL-Arginine for Injection, all strengths and presentations recalledGenoGenixSterilityNationwide
CLASS IITri-Immune for Injection, all strengths and presentations recalledGenoGenixSterilityNationwide
CLASS IIVitamin D3 for Injection, all strengths and presentations recalledGenoGenixSterilityNationwide
CLASS IIBPC-157 for Injection, 15mg/ vial, all presentations recalledGenoGenixSterilityNationwide
CLASS IIRetatrutide for Injection, 60mg / vial, all presentations recalledGenoGenixSterilityNationwide
CLASS IIGlutathione Magnesium for Injection, all strengths recalled by GenoGenixGenoGenixSterilityNationwide
CLASS IIGlutathione Preserved for Injection, all strengths recalled by GenoGenixGenoGenixSterilityNationwide
CLASS IIOxytocin for Injection, all strengths and presentations recalledGenoGenixSterilityNationwide
CLASS IIB12 Hydroxocobalamin for Injection, all strengths recalled by GenoGenixGenoGenixSterilityNationwide
CLASS IIEDTA for Injection, all strengths and presentations recalledGenoGenixSterilityNationwide
CLASS IILipo MIC + L-Carnitine for Injection, all strengths recalledGenoGenixSterilityNationwide
CLASS IIAlpha Lipoic Acid for Injection, all strengths recalled by GenoGenixGenoGenixSterilityNationwide
CLASS IIB5 Dexpanthenol for Injection, all strengths recalled by GenoGenixGenoGenixSterilityNationwide
CLASS IIProline for Injection, all strengths and presentations recalledGenoGenixSterilityNationwide
CLASS IISemaglutide for Injection, a) 20 mg b) 20 mg/mL Multi-Dose recalledGenoGenixSterilityNationwide
CLASS IIpH Buffered Reconstitution Solution for Injection recalled by GenoGenixGenoGenixSterilityNationwide
CLASS IIElite Stack MSC Exosome Reconstitution Solution recalled by GenoGenixGenoGenixSterilityNationwide
CLASS IIElite Stack Reconstitution Solution for Injection recalled by GenoGenixGenoGenixSterilityNationwide
CLASS IIAscorbic Acid (Vitamin C) for Injection, Preservative Free recalledGenoGenixSterilityNationwide
CLASS IIB12 Methylcobalamin for Injection, all strengths recalled by GenoGenixGenoGenixSterilityNationwide
CLASS IIGAC for Injection, all strengths and presentations recalled by GenoGenixGenoGenixSterilityNationwide
CLASS IIB-Complex for Injection, all strengths and presentations recalledGenoGenixSterilityNationwide
CLASS IIPentosan for Injection, all strengths and presentations recalledGenoGenixSterilityNationwide
CLASS IIEpithalon for Injection, 20mg, all presentations, GenoGenix recalledGenoGenixSterilityNationwide
CLASS IIZinc Sulfate for Injection, all strengths and presentations recalledGenoGenixSterilityNationwide
CLASS INAD+ (Nicotinamide adenine dinucleotide) for Injection recalledGenoGenixSterilityNationwide
CLASS IICoQ10 for Injection, all strengths and presentations recalledGenoGenixSterilityNationwide
CLASS IILipo MIC +B12 Methylcobalamin for Injection recalled by GenoGenixGenoGenixSterilityNationwide
CLASS IIL-Glutamine for Injection, all strengths and presentations recalledGenoGenixSterilityNationwide
CLASS IIZinc Chloride for Injection, all strengths recalled by GenoGenixGenoGenixSterilityNationwide
CLASS IIAscorbic Acid (Vitamin C) for Injection, Preserved recalled by GenoGenixGenoGenixSterilityNationwide
CLASS IIThymosin Beta-4 (TB4) for Injection, 15mg recalled by GenoGenixGenoGenixSterilityNationwide
CLASS IIL-Arginine HCl for Injection, all strengths recalled by GenoGenixGenoGenixSterilityNationwide
CLASS IILow Solubility Peptide Reconstitution Solution recalled by GenoGenixGenoGenixSterilityNationwide
CLASS IIBPC-157/Thymosin Beta-4 for Injection, a) 10/10mg recalled by GenoGenixGenoGenixSterilityNationwide
CLASS IISermorelin Lyophilized powder for reconstitution, 10mg recalledGenoGenixSterilityNationwide
CLASS IIB6 (Pyridoxine HCl) for Injections, all strengths recalled by GenoGenixGenoGenixSterilityNationwide
CLASS IISterile Saline Reconstitution Solution for Injection recalledGenoGenixSterilityNationwide
CLASS IISemaglutide with B12 for Injection, all strengths recalled by GenoGenixGenoGenixSterilityNationwide
CLASS IIUltra Burn for Injection, all strengths and presentations recalledGenoGenixSterilityNationwide

More recalls from GenoGenix

All 57
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIUltra Burn for Injection, all strengths and presentations recalledGenoGenixSterilityNationwide
DrugCLASS IISemaglutide with B12 for Injection, all strengths recalled by GenoGenixGenoGenixSterilityNationwide
DrugCLASS IISterile Saline Reconstitution Solution for Injection recalledGenoGenixSterilityNationwide
DrugCLASS IIB6 (Pyridoxine HCl) for Injections, all strengths recalled by GenoGenixGenoGenixSterilityNationwide
DrugCLASS IISermorelin Lyophilized powder for reconstitution, 10mg recalledGenoGenixSterilityNationwide