The Recall Desk

Manufacturer

GenoGenix LLC

57 recalls in our database name GenoGenix LLC as the manufacturing or recalling firm.

What the numbers show

Total
57
Critical
1
Severe
0
Most recent
2025-10-15

Of the 57 recalls from GenoGenix LLC we have scored against our rubric, 1 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 57

  • CriticalFDA (Drugs)·D-0094-2026·2025-10-15

    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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0088-2026·2025-10-15

    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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0046-2026·2025-10-15

    Bacteriostatic water for injection recalled over lack of sterility assurance

    GenoGenix is recalling Bacteriostatic Water for Injection in all strengths and presentations, covering all lots within expiry, for 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
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0061-2026·2025-10-15

    Lysine for injection recalled across all lots over sterility assurance

    GenoGenix is recalling Lysine for Injection in all strengths and presentations, covering all lots within expiry, for 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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0040-2026·2025-10-15

    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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0052-2026·2025-10-15

    Glutathione magnesium injection recalled across all lots over sterility assurance

    GenoGenix is recalling Glutathione Magnesium for Injection in all strengths and presentations, covering all lots within expiry, for 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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0092-2026·2025-10-15

    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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0057-2026·2025-10-15

    L-Carnitine for injection recalled across all lots over sterility assurance

    GenoGenix is recalling L-Carnitine for Injection in all strengths and presentations, covering all lots within expiry, for 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
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0084-2026·2025-10-15

    Zinc chloride injection recalled across all lots for lack of sterility

    GenoGenix is recalling Zinc Chloride for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.

    Product
    Zinc Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0083-2026·2025-10-15

    Semaglutide with B12 injection recalled across all lots over sterility

    GenoGenix is recalling Semaglutide with B12 for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.

    Product
    Semaglutide with B12 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0071-2026·2025-10-15

    Cerebrolysin injection recalled across all lots for lack of sterility assurance

    GenoGenix is recalling Cerebrolysin for Injection in all strengths and presentations, covering all lots within expiry, for 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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0047-2026·2025-10-15

    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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0045-2026·2025-10-15

    Pyridoxine B6 injection recalled across all lots over sterility assurance

    GenoGenix is recalling B6 (Pyridoxine HCl) for Injections in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.

    Product
    B6 (Pyridoxine HCl) for Injections, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Synergy Wellness
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0066-2026·2025-10-15

    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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0080-2026·2025-10-15

    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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0044-2026·2025-10-15

    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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0076-2026·2025-10-15

    Low solubility peptide solution recalled across all lots over sterility assurance

    GenoGenix is recalling Low Solubility Peptide Reconstitution Solution for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.

    Product
    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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0049-2026·2025-10-15

    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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0078-2026·2025-10-15

    Pentosan for injection recalled across all lots over sterility assurance

    GenoGenix is recalling Pentosan for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.

    Product
    Pentosan for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0054-2026·2025-10-15

    Glycine for injection recalled across all lots over sterility assurance

    GenoGenix is recalling Glycine for Injection in all strengths and presentations, covering all lots within expiry, for 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
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0089-2026·2025-10-15

    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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0055-2026·2025-10-15

    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
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0093-2026·2025-10-15

    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
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0082-2026·2025-10-15

    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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0065-2026·2025-10-15

    NAD+ injection recalled across all lots for lack of sterility assurance

    GenoGenix is recalling NAD+ injection at 50 mg/mL and 100 mg/mL in 10 mL multi-dose vials, covering all lots within expiry, for 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
    Category
    Drug
    Distribution
    Distributed nationwide