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
Tirzepatide injection recalled from two lots over lack of sterility assurance
GenoGenix is recalling Tirzepatide 60mg/10 mL for Injection from two lots for 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.
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HighFDA (Drugs)··2025-10-15
Buffered reconstitution solution recalled across all lots over sterility assurance
GenoGenix is recalling pH Buffered Reconstitution Solution for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
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.
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HighFDA (Drugs)··2025-10-15
B-Complex injection recalled across all lots over lack of sterility assurance
GenoGenix is recalling B-Complex for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
Product
B-Complex for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. B-Complex with B12 also labeled as manufactured for Synergy Wellness.
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HighFDA (Drugs)··2025-10-15
Taurine for injection recalled across all lots over sterility assurance
GenoGenix is recalling Taurine for Injection in all strengths and presentations, covering all lots within expiry, for 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.
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HighFDA (Drugs)··2025-10-15
Ascorbic acid injection recalled across all lots for sterility assurance concerns
GenoGenix is recalling preservative-free Ascorbic Acid (Vitamin C) for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
Product
Ascorbic Acid (Vitamin C) for Injection, Preservative Free, 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
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
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
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
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
Dexpanthenol B5 injection recalled across all lots over sterility assurance
GenoGenix is recalling B5 Dexpanthenol for Injection in all strengths and presentations, covering all lots within expiry, for 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.
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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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0 states
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
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
Epithalon injection recalled from one lot for lack of sterility assurance
GenoGenix is recalling Epithalon for Injection, 20mg, in all presentations from a single lot for lack of assurance of sterility.
Product
Epithalon for Injection, 20mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 manufactured for Extension Health.
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HighFDA (Drugs)··2025-10-15
Sterile saline reconstitution solution recalled across all lots over sterility assurance
GenoGenix is recalling Sterile Saline Reconstitution Solution for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
Product
Sterile Saline Reconstitution Solution 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
Tesamorelin injection recalled from one lot for lack of sterility assurance
GenoGenix is recalling Tesamorelin for Injection, 15mg in a 10 mL multi-dose vial, from a single lot for 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.
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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
Calcium chloride injection recalled across all lots over sterility assurance
GenoGenix is recalling Calcium Chloride for Injection in all strengths and presentations, covering all lots within expiry, for 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.
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HighFDA (Drugs)··2025-10-15
Retatrutide injection recalled from one lot for lack of sterility assurance
GenoGenix is recalling Retatrutide for Injection, 60mg/10mL vial, from a single lot for 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
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HighFDA (Drugs)··2025-10-15
L-Arginine for injection recalled across all lots over sterility assurance
GenoGenix is recalling L-Arginine for Injection in all strengths and presentations, covering all lots within expiry, for 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
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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
EDTA for injection recalled across all lots over sterility assurance
GenoGenix is recalling EDTA for Injection in all strengths and presentations, covering all lots within expiry, for 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.
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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
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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