FDA (Drugs) recall action 97369

GenoGenix LLC recalled 57 products on 2025-10-15

The FDA (Drugs) publishes a recall like this one as 57 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 57 pages.

Products: 57
Announced: 2025-10-15
Critical: 1
Units: 6,365

Why these products were recalled

Lack of Assurance of Sterility

Microbial Contamination of Sterile Products: elevated endotoxin levels

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

26–50 of 57

HighFDA (Drugs)··2025-10-15
Elite Stack reconstitution solution recalled across all lots over sterility assurance
GenoGenix is recalling Elite Stack Reconstitution Solution for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
Product
Elite Stack 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 Extension Health and Medical Health Institute (MHI).
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HighFDA (Drugs)··2025-10-15
Methylene blue injection recalled across all lots for sterility assurance concerns
GenoGenix is recalling Methylene Blue for Injection in all strengths and presentations, covering all lots within expiry, for 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.
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HighFDA (Drugs)··2025-10-15
Oxytocin for injection recalled across all lots over sterility assurance
GenoGenix is recalling Oxytocin for Injection in all strengths and presentations, covering all lots within expiry, for 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.
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HighFDA (Drugs)··2025-10-15
Sermorelin lyophilized powder recalled from one lot over sterility assurance
GenoGenix is recalling Sermorelin lyophilized powder for reconstitution, 10mg in a 10 mL multi-dose vial, from a single lot for lack of assurance of sterility.
Product
Sermorelin Lyophilized powder for reconstitution, 10mg, Vial capacity 10 mL Multi-Dose, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
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HighFDA (Drugs)··2025-10-15
Semaglutide injection recalled from two lots for lack of sterility assurance
GenoGenix is recalling Semaglutide for Injection, 20 mg in 10 mL multi-dose vials, from two lots for lack of assurance of sterility.
Product
Semaglutide for Injection, a) 20 mg b) 20 mg/mL, 10 mL Multi-Dose Vials, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Synergy Wellness, 20 mg, 10mL vial lyophilized.
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HighFDA (Drugs)··2025-10-15
Hydroxocobalamin B12 injection recalled across all lots for sterility assurance
GenoGenix is recalling B12 Hydroxocobalamin for Injection in all strengths and presentations, covering all lots within expiry, for 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.
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HighFDA (Drugs)··2025-10-15
GAC injection recalled across all lots for lack of sterility assurance
GenoGenix is recalling GAC for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
Product
GAC for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
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HighFDA (Drugs)··2025-10-15
Biotin for injection recalled across all lots over sterility assurance
GenoGenix is recalling Biotin for Injection in all strengths and presentations, covering all lots within expiry, for 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.
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HighFDA (Drugs)··2025-10-15
Alpha lipoic acid injection recalled across all lots over sterility assurance
GenoGenix is recalling Alpha Lipoic Acid for Injection in all strengths and presentations, covering all lots within expiry, for 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.
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HighFDA (Drugs)··2025-10-15
L-Glutamine for injection recalled across all lots over sterility assurance
GenoGenix is recalling L-Glutamine for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
Product
L-Glutamine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
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HighFDA (Drugs)··2025-10-15
Lipo MIC with B12 injection recalled across all lots over sterility
GenoGenix is recalling Lipo MIC + B12 Methylcobalamin for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
Product
Lipo MIC +B12 Methylcobalamin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
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HighFDA (Drugs)··2025-10-15
Amino blend for injection recalled across all lots over sterility assurance
GenoGenix is recalling Amino Blend for Injection in all strengths and presentations, covering all lots within expiry, for 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
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HighFDA (Drugs)··2025-10-15
N-Acetyl-L-Cysteine injection recalled across all lots over sterility assurance
GenoGenix is recalling N-Acetyl-L-Cysteine for Injection in all strengths and presentations, covering all lots within expiry, for 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.
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HighFDA (Drugs)··2025-10-15
BPC-157 injection recalled from one lot for lack of sterility assurance
GenoGenix is recalling BPC-157 for Injection, 15mg/10mL vial, from a single lot for 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.
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HighFDA (Drugs)··2025-10-15
Magnesium chloride injection recalled across all lots over sterility assurance
GenoGenix is recalling Magnesium Chloride for Injection in all strengths and presentations, covering all lots within expiry, for 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.
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HighFDA (Drugs)··2025-10-15
Tri-Immune injection recalled across all lots over lack of sterility assurance
GenoGenix is recalling Tri-Immune for Injection in all strengths and presentations, covering all lots within expiry, for 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.
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CriticalFDA (Drugs)··2025-10-15
NAD+ injection recalled after elevated endotoxin levels found in one lot
GenoGenix is recalling NAD+ for Injection at 100 mg/mL and 200 mg/mL from one lot for microbial contamination of sterile products, with elevated endotoxin levels.
Product
NAD+ (Nicotinamide adenine dinucleotide) for Injection, a) 100 mg/mL b) 200 mg/mL, 10 mL multi-dose amber vials, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
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HighFDA (Drugs)··2025-10-15
CoQ10 for injection recalled across all lots over sterility assurance
GenoGenix is recalling CoQ10 for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
Product
CoQ10 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
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HighFDA (Drugs)··2025-10-15
Lipo MIC with L-Carnitine injection recalled over lack of sterility assurance
GenoGenix is recalling Lipo MIC + L-Carnitine for Injection in all strengths and presentations, covering all lots within expiry, for 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.
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HighFDA (Drugs)··2025-10-15
Exosome reconstitution solution recalled across all lots over sterility assurance
GenoGenix is recalling Elite Stack MSC Exosome Reconstitution Solution for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
Product
Elite Stack MSC Exosome 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 Extension Health, a) 22 billion per vial, 8mL of solution in 10mL vial, b) 44…
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HighFDA (Drugs)··2025-10-15
Zinc sulfate injection recalled across all lots for sterility assurance concerns
GenoGenix is recalling Zinc Sulfate for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
Product
Zinc Sulfate for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
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HighFDA (Drugs)··2025-10-15
Preserved glutathione injection recalled across all lots for sterility assurance
GenoGenix is recalling Glutathione Preserved for Injection in all strengths and presentations, covering all lots within expiry, for 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
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HighFDA (Drugs)··2025-10-15
Methylcobalamin B12 injection recalled across all lots over sterility assurance
GenoGenix is recalling B12 Methylcobalamin for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
Product
B12 Methylcobalamin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as, manufactured for Synergy Wellness.
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HighFDA (Drugs)··2025-10-15
Vitamin D3 for injection recalled across all lots over sterility assurance
GenoGenix is recalling Vitamin D3 for Injection in all strengths and presentations, covering all lots within expiry, for 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.
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HighFDA (Drugs)··2025-10-15
Reconstitution XO solution recalled across all lots over sterility assurance
GenoGenix is recalling Reconstitution XO Solution for Injection in all strengths and presentations, covering all lots within expiry, for 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%…
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