Category
Drug and pharmaceutical recalls
17622 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2025-10-22FDA-DrugIntegraDose Compounding Services LLCClass IOxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use, Rx only, IntegraDose Compounding Services LLC, 719 Kasota Ave Se, Minneapolis, MN 55414-2842 NDC 71139-0012-1
Subpotent Drug: Testing revealed there was no oxytocin in the IV bag.
- 2025-10-15FDA-DrugGenoGenix LLCClass INAD+ (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.
Microbial Contamination of Sterile Products: elevated endotoxin levels
- 2025-10-15FDA-DrugGenoGenix LLCClass IIRetatrutide for Injection, 60mg / 10mL vial, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692
Lack of Assurance of Sterility
- 2025-10-15FDA-DrugGenoGenix LLCClass IITirzepatide, 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.
Lack of Assurance of Sterility
- 2025-10-15FDA-DrugGenoGenix LLCClass IISemaglutide for Injection, a) 20 mg b) 20 mg/mL, 10 mL Multi-Dose Vials, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Synergy Wellness, 20 mg, 10mL vial lyophilized.
Lack of Assurance of Sterility
- 2025-10-15FDA-DrugGenoGenix LLCClass IISermorelin Lyophilized powder for reconstitution, 10mg, Vial capacity 10 mL Multi-Dose, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
- 2025-10-15FDA-DrugGenoGenix LLCClass IIEpithalon for Injection, 20mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 manufactured for Extension Health.
Lack of Assurance of Sterility
- 2025-10-15FDA-DrugGenoGenix LLCClass IITesamorelin for Injection, 15mg, 10 mL Multi-Dose Vial, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
- 2025-10-15FDA-DrugGenoGenix LLCClass IIThymosin Beta-4 (TB4) for Injection, 15mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
- 2025-10-15FDA-DrugGenoGenix LLCClass IIBPC-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).
Lack of Assurance of Sterility
- 2025-10-15FDA-DrugGenoGenix LLCClass IIBPC-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.
Lack of Assurance of Sterility
- 2025-10-15FDA-DrugGenoGenix LLCClass IIZinc Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
- 2025-10-15FDA-DrugGenoGenix LLCClass IISemaglutide with B12 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
- 2025-10-15FDA-DrugGenoGenix LLCClass IISterile Saline Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
- 2025-10-15FDA-DrugGenoGenix LLCClass IIReconstitution 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.
Lack of Assurance of Sterility
- 2025-10-15FDA-DrugGenoGenix LLCClass IIpH 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.
Lack of Assurance of Sterility
- 2025-10-15FDA-DrugGenoGenix LLCClass IIProline for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
- 2025-10-15FDA-DrugGenoGenix LLCClass IIPentosan for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
- 2025-10-15FDA-DrugGenoGenix LLCClass IIOxytocin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
- 2025-10-15FDA-DrugGenoGenix LLCClass IILow 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.
Lack of Assurance of Sterility
- 2025-10-15FDA-DrugGenoGenix LLCClass IIElite 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).
Lack of Assurance of Sterility
- 2025-10-15FDA-DrugGenoGenix LLCClass IIElite 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.
Lack of Assurance of Sterility
- 2025-10-15FDA-DrugGenoGenix LLCClass IIEDTA for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
- 2025-10-15FDA-DrugGenoGenix LLCClass IICoQ10 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
- 2025-10-15FDA-DrugGenoGenix LLCClass IICerebrolysin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
- 2025-10-15FDA-DrugGenoGenix LLCClass IIZinc Sulfate for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
- 2025-10-15FDA-DrugGenoGenix LLCClass IIVitamin D3 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
- 2025-10-15FDA-DrugGenoGenix LLCClass IIUltra Burn for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
- 2025-10-15FDA-DrugGenoGenix LLCClass IITri-Immune for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
- 2025-10-15FDA-DrugGenoGenix LLCClass IITaurine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
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