The Recall Desk

Hazard

Sterility Assurance recalls

663 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
663
Critical
0
Severe
261
Most recent
2026-08-26

Of the 663 sterility assurance recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 261 (39%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all sterility assurance recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

176–200 of 663

  • HighFDA (Drugs)·D-0077-2026·2025-10-15

    Oxytocin for injection recalled across all lots over sterility assurance

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

    Product
    Oxytocin 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
  • 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-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-0056-2026·2025-10-15

    L-Arginine HCl injection recalled across all lots over sterility assurance

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

    Product
    L-Arginine HCl 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-0062-2026·2025-10-15

    Magnesium chloride injection recalled across all lots over sterility assurance

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

    Product
    Magnesium 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-0087-2026·2025-10-15

    Thymosin Beta-4 injection recalled from one lot over sterility assurance

    GenoGenix is recalling Thymosin Beta-4 (TB4) for Injection, 15mg, in all presentations from a single lot for lack of assurance of sterility.

    Product
    Thymosin Beta-4 (TB4) for Injection, 15mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
    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-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-0090-2026·2025-10-15

    Sermorelin lyophilized powder recalled from one lot over sterility assurance

    GenoGenix is recalling Sermorelin lyophilized powder for reconstitution, 10mg in a 10 mL multi-dose vial, from a single lot for lack of assurance of sterility.

    Product
    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.
    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-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-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-0081-2026·2025-10-15

    Reconstitution XO solution recalled across all lots over sterility assurance

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

    Product
    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,
    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-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-0069-2026·2025-10-15

    Vitamin D3 for injection recalled across all lots over sterility assurance

    GenoGenix is recalling Vitamin D3 for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.

    Product
    Vitamin D3 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-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-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-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-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-0060-2026·2025-10-15

    Lipo MIC with B12 injection recalled across all lots over sterility

    GenoGenix is recalling Lipo MIC + B12 Methylcobalamin for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.

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