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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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Showing 701–720 of 17,898 drug recalls

Drug Recall Ongoing Historical recordClass II

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.

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

Epithalon for Injection, 20mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 manufactured for Extension 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

Tesamorelin for Injection, 15mg, 10 mL Multi-Dose Vial, 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

Thymosin Beta-4 (TB4) for Injection, 15mg, all 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

BPC-157/Thymosin Beta-4 for Injection, a) 10/10mg, b) 15/15mg, c) 15mg/15mg, all 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 (MHI).

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

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.

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

Zinc 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

Semaglutide with B12 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

Sterile Saline Reconstitution Solution 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

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.

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

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.

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

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.

View recall →

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.

View recall →

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.

View recall →

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.

View recall →

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.

View recall →

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.

View recall →

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.

View recall →

Data last updated:

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.