thejoe GenoGenix LLC

GenoGenix LLC: 57 FDA recall reports

Every drug recall the FDA has published for GenoGenix LLC. The fault, and how the agency graded it.

57Reports

1Class I

57Ongoing

2025-10-15Most recent

1 Class I on this page

Class I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class II	56
Class I	1

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Reconstitution XO Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste

D-0081-2026 · Class II · reported 2025-10-15 · Ongoing

Why it was recalled: Lack of Assurance of Sterility
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.
Where it went: US Nationwide.

Glycine for Injection, all strengths and presentations, GenoGenix LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL

D-0054-2026 · Class II · reported 2025-10-15 · Ongoing

Why it was recalled: Lack of Assurance of Sterility
Product: Glycine for Injection, all strengths and presentations, GenoGenix LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692
Where it went: US Nationwide.
How much: 32

GHK-Cu (Copper Peptide) for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 20

D-0051-2026 · Class II · reported 2025-10-15 · Ongoing

Why it was recalled: Lack of Assurance of Sterility
Product: GHK-Cu (Copper Peptide) for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Where it went: US Nationwide.
How much: 221

Magnesium Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boc

D-0062-2026 · Class II · reported 2025-10-15 · Ongoing

Why it was recalled: Lack of Assurance of Sterility
Product: Magnesium Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Where it went: US Nationwide.
How much: 430

Cerebrolysin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Rato

D-0071-2026 · Class II · reported 2025-10-15 · Ongoing

Why it was recalled: Lack of Assurance of Sterility
Product: Cerebrolysin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Where it went: US Nationwide.

L-Carnitine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton

D-0057-2026 · Class II · reported 2025-10-15 · Ongoing

Why it was recalled: Lack of Assurance of Sterility
Product: L-Carnitine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692
Where it went: US Nationwide.
How much: 161

N-Acetyl-L-Cysteine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Bo

D-0064-2026 · Class II · reported 2025-10-15 · Ongoing

Why it was recalled: Lack of Assurance of Sterility
Product: N-Acetyl-L-Cysteine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Where it went: US Nationwide.
How much: 85

NAD+ (Nicotinamide adenine dinucleotide), a) 50 mg/mL, b) 100 mg/mL, 10 mL multi-dose vials, all strengths and

D-0065-2026 · Class II · reported 2025-10-15 · Ongoing

Why it was recalled: Lack of Assurance of Sterility
Product: NAD+ (Nicotinamide adenine dinucleotide), a) 50 mg/mL, b) 100 mg/mL, 10 mL multi-dose vials, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health
Where it went: US Nationwide.

Methylene Blue for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Ra

D-0063-2026 · Class II · reported 2025-10-15 · Ongoing

Why it was recalled: Lack of Assurance of Sterility
Product: Methylene Blue for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Where it went: US Nationwide.
How much: 30

Lysine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL

D-0061-2026 · Class II · reported 2025-10-15 · Ongoing

Why it was recalled: Lack of Assurance of Sterility
Product: Lysine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Where it went: US Nationwide.
How much: 45

Biotin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL

D-0048-2026 · Class II · reported 2025-10-15 · Ongoing

Why it was recalled: Lack of Assurance of Sterility
Product: Biotin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Where it went: US Nationwide.
How much: 296

Calcium Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca

D-0049-2026 · Class II · reported 2025-10-15 · Ongoing

Why it was recalled: Lack of Assurance of Sterility
Product: Calcium Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Where it went: US Nationwide.
How much: 184

Amino Blend for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton

D-0039-2026 · Class II · reported 2025-10-15 · Ongoing

Why it was recalled: Lack of Assurance of Sterility
Product: Amino Blend for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692
Where it went: US Nationwide.
How much: 235

Tesamorelin for Injection, 15mg, 10 mL Multi-Dose Vial, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL

D-0088-2026 · Class II · reported 2025-10-15 · Ongoing

Why it was recalled: Lack of Assurance of Sterility
Product: Tesamorelin for Injection, 15mg, 10 mL Multi-Dose Vial, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Where it went: US Nationwide.

Tirzepatide, 60mg/10 mL for Injection, 10mL vial lyophilized, all presentations, GenoGenix, LLC, 2840 NW 2nd A

D-0092-2026 · Class II · reported 2025-10-15 · Ongoing

Why it was recalled: Lack of Assurance of Sterility
Product: Tirzepatide, 60mg/10 mL for Injection, 10mL vial lyophilized, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Extension Health and Synergy Wellness 60mg, 10mL vial lyophilized.
Where it went: US Nationwide.

Bacteriostatic Water for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 B

D-0046-2026 · Class II · reported 2025-10-15 · Ongoing

Why it was recalled: Lack of Assurance of Sterility
Product: Bacteriostatic Water 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, Extension Health and Medical Health Institute
Where it went: US Nationwide.

Taurine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL

D-0066-2026 · Class II · reported 2025-10-15 · Ongoing

Why it was recalled: Lack of Assurance of Sterility
Product: Taurine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Where it went: US Nationwide.
How much: 294

L-Arginine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton,

D-0055-2026 · Class II · reported 2025-10-15 · Ongoing

Why it was recalled: Lack of Assurance of Sterility
Product: L-Arginine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692
Where it went: US Nationwide.
How much: 53

Tri-Immune for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton,

D-0067-2026 · Class II · reported 2025-10-15 · Ongoing

Why it was recalled: Lack of Assurance of Sterility
Product: Tri-Immune for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Where it went: US Nationwide.
How much: 166

Vitamin D3 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton,

D-0069-2026 · Class II · reported 2025-10-15 · Ongoing

Why it was recalled: Lack of Assurance of Sterility
Product: Vitamin D3 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Where it went: US Nationwide.
How much: 339

BPC-157 for Injection, 15mg/10mL vial, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton,

D-0085-2026 · Class II · reported 2025-10-15 · Ongoing

Why it was recalled: Lack of Assurance of Sterility
Product: BPC-157 for Injection, 15mg/10mL vial, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Medical Health Institute (MHI), 15mg, 10mL vial lyophilized.
Where it went: US Nationwide.

Retatrutide for Injection, 60mg / 10mL vial, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca R

D-0093-2026 · Class II · reported 2025-10-15 · Ongoing

Why it was recalled: Lack of Assurance of Sterility
Product: Retatrutide for Injection, 60mg / 10mL vial, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692
Where it went: US Nationwide.

Glutathione Magnesium for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204

D-0052-2026 · Class II · reported 2025-10-15 · Ongoing

Why it was recalled: Lack of Assurance of Sterility
Product: Glutathione Magnesium 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.
Where it went: US Nationwide.

Glutathione Preserved for Injection, all strengths and presentations, GenoGenix LLC, 2840 NW 2nd Ave Ste 204 B

D-0053-2026 · Class II · reported 2025-10-15 · Ongoing

Why it was recalled: Lack of Assurance of Sterility
Product: Glutathione Preserved for Injection, all strengths and presentations, GenoGenix LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692
Where it went: US Nationwide.
How much: 907

Oxytocin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, F

D-0077-2026 · Class II · reported 2025-10-15 · Ongoing

Why it was recalled: Lack of Assurance of Sterility
Product: Oxytocin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Where it went: US Nationwide.

B12 Hydroxocobalamin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 B

D-0042-2026 · Class II · reported 2025-10-15 · Ongoing

Why it was recalled: Lack of Assurance of Sterility
Product: B12 Hydroxocobalamin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Where it went: US Nationwide.
How much: 25

EDTA for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33

D-0073-2026 · Class II · reported 2025-10-15 · Ongoing

Why it was recalled: Lack of Assurance of Sterility
Product: EDTA for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Where it went: US Nationwide.

Lipo MIC + L-Carnitine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204

D-0059-2026 · Class II · reported 2025-10-15 · Ongoing

Why it was recalled: Lack of Assurance of Sterility
Product: Lipo MIC + L-Carnitine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Where it went: US Nationwide.
How much: 172

Alpha Lipoic Acid for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca

D-0038-2026 · Class II · reported 2025-10-15 · Ongoing

Why it was recalled: Lack of Assurance of Sterility
Product: Alpha Lipoic Acid for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Where it went: US Nationwide.
How much: 17

B5 Dexpanthenol for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca R

D-0044-2026 · Class II · reported 2025-10-15 · Ongoing

Why it was recalled: Lack of Assurance of Sterility
Product: B5 Dexpanthenol for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Where it went: US Nationwide.
How much: 35

Showing the 30 most recent of 57. The rest are searchable at the FDA enforcement report database.

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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