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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Drug Recall Ongoing Historical recordClass II

Proline for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

by GenoGenix LLC

Reason: Lack of Assurance of Sterility
Recall initiated: July 30, 2025
Reported by FDA: October 15, 2025
Distribution: US Nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

Pentosan for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

by GenoGenix LLC

Reason: Lack of Assurance of Sterility
Recall initiated: July 30, 2025
Reported by FDA: October 15, 2025
Distribution: US Nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

Oxytocin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

by GenoGenix LLC

Reason: Lack of Assurance of Sterility
Recall initiated: July 30, 2025
Reported by FDA: October 15, 2025
Distribution: US Nationwide.

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Drug Recall Ongoing Historical recordClass II

Low Solubility Peptide 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 CELIA Health.

by GenoGenix LLC

Reason: Lack of Assurance of Sterility
Recall initiated: July 30, 2025
Reported by FDA: October 15, 2025
Distribution: US Nationwide.

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Drug Recall Ongoing Historical recordClass II

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).

by GenoGenix LLC

Reason: Lack of Assurance of Sterility
Recall initiated: July 30, 2025
Reported by FDA: October 15, 2025
Distribution: US Nationwide.

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Drug Recall Ongoing Historical recordClass II

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 billion per vial, 8mL of solution in 10mL vial.

by GenoGenix LLC

Reason: Lack of Assurance of Sterility
Recall initiated: July 30, 2025
Reported by FDA: October 15, 2025
Distribution: US Nationwide.

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Drug Recall Ongoing Historical recordClass II

EDTA for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

by GenoGenix LLC

Reason: Lack of Assurance of Sterility
Recall initiated: July 30, 2025
Reported by FDA: October 15, 2025
Distribution: US Nationwide.

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Drug Recall Ongoing Historical recordClass II

CoQ10 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

by GenoGenix LLC

Reason: Lack of Assurance of Sterility
Recall initiated: July 30, 2025
Reported by FDA: October 15, 2025
Distribution: US Nationwide.

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Drug Recall Ongoing Historical recordClass II

Cerebrolysin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

by GenoGenix LLC

Reason: Lack of Assurance of Sterility
Recall initiated: July 30, 2025
Reported by FDA: October 15, 2025
Distribution: US Nationwide.

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Drug Recall Ongoing Historical recordClass II

Zinc Sulfate for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

by GenoGenix LLC

Reason: Lack of Assurance of Sterility
Recall initiated: July 30, 2025
Reported by FDA: October 15, 2025
Distribution: US Nationwide.

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Drug Recall Ongoing Historical recordClass II

Vitamin D3 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

by GenoGenix LLC

Reason: Lack of Assurance of Sterility
Recall initiated: July 30, 2025
Reported by FDA: October 15, 2025
Distribution: US Nationwide.

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Drug Recall Ongoing Historical recordClass II

Ultra Burn for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

by GenoGenix LLC

Reason: Lack of Assurance of Sterility
Recall initiated: July 30, 2025
Reported by FDA: October 15, 2025
Distribution: US Nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

Tri-Immune for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

by GenoGenix LLC

Reason: Lack of Assurance of Sterility
Recall initiated: July 30, 2025
Reported by FDA: October 15, 2025
Distribution: US Nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

Taurine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

by GenoGenix LLC

Reason: Lack of Assurance of Sterility
Recall initiated: July 30, 2025
Reported by FDA: October 15, 2025
Distribution: US Nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

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

by GenoGenix LLC

Reason: Lack of Assurance of Sterility
Recall initiated: July 30, 2025
Reported by FDA: October 15, 2025
Distribution: US Nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

N-Acetyl-L-Cysteine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

by GenoGenix LLC

Reason: Lack of Assurance of Sterility
Recall initiated: July 30, 2025
Reported by FDA: October 15, 2025
Distribution: US Nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

Methylene Blue for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

by GenoGenix LLC

Reason: Lack of Assurance of Sterility
Recall initiated: July 30, 2025
Reported by FDA: October 15, 2025
Distribution: US Nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

Magnesium Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

by GenoGenix LLC

Reason: Lack of Assurance of Sterility
Recall initiated: July 30, 2025
Reported by FDA: October 15, 2025
Distribution: US Nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

Lysine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

by GenoGenix LLC

Reason: Lack of Assurance of Sterility
Recall initiated: July 30, 2025
Reported by FDA: October 15, 2025
Distribution: US Nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

Lipo MIC +B12 Methylcobalamin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

by GenoGenix LLC

Reason: Lack of Assurance of Sterility
Recall initiated: July 30, 2025
Reported by FDA: October 15, 2025
Distribution: US Nationwide.

View recall →

Data last updated: October 30, 2026 ET

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.