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.

26–50 of 57

  • 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-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-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-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-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-0064-2026·2025-10-15

    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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0039-2026·2025-10-15

    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
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0053-2026·2025-10-15

    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
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0070-2026·2025-10-15

    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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0038-2026·2025-10-15

    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.
    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-0067-2026·2025-10-15

    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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0050-2026·2025-10-15

    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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0058-2026·2025-10-15

    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.
    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-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-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-0063-2026·2025-10-15

    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.
    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-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-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-0085-2026·2025-10-15

    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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0073-2026·2025-10-15

    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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0075-2026·2025-10-15

    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).
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0043-2026·2025-10-15

    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.
    Category
    Drug
    Distribution
    Distributed nationwide