Agency
FDA drug recalls
Formal FDA enforcement reports for prescription and over-the-counter drugs — contamination, wrong potency, mislabeling, and manufacturing failures.
768 recalls in the last 12 months, translated into plain English.
- 2025-10-15GenoGenix 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
- 2025-10-15GenoGenix 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
- 2025-10-15GenoGenix 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
- 2025-10-15GenoGenix LLCClass IINAD+ (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
Lack of Assurance of Sterility
- 2025-10-15GenoGenix LLCClass IIN-Acetyl-L-Cysteine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
- 2025-10-15GenoGenix LLCClass IIMethylene Blue for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
- 2025-10-15GenoGenix LLCClass IIMagnesium 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
- 2025-10-15GenoGenix LLCClass IILysine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
- 2025-10-15GenoGenix LLCClass IILipo MIC +B12 Methylcobalamin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
- 2025-10-15GenoGenix LLCClass IILipo MIC + L-Carnitine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
- 2025-10-15GenoGenix LLCClass IIL-Glutamine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
- 2025-10-15GenoGenix LLCClass IIL-Carnitine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692
Lack of Assurance of Sterility
- 2025-10-15GenoGenix LLCClass IIL-Arginine HCl for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
- 2025-10-15GenoGenix LLCClass IIL-Arginine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692
Lack of Assurance of Sterility
- 2025-10-15GenoGenix LLCClass IIGlycine for Injection, all strengths and presentations, GenoGenix LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692
Lack of Assurance of Sterility
- 2025-10-15GenoGenix LLCClass IIGlutathione Preserved for Injection, all strengths and presentations, GenoGenix LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692
Lack of Assurance of Sterility
- 2025-10-15GenoGenix LLCClass IIGlutathione 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.
Lack of Assurance of Sterility
- 2025-10-15GenoGenix LLCClass IIGHK-Cu (Copper Peptide) for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
- 2025-10-15GenoGenix LLCClass IIGAC for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
- 2025-10-15GenoGenix LLCClass IICalcium 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
- 2025-10-15GenoGenix LLCClass IIBiotin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
- 2025-10-15GenoGenix LLCClass IIB-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.
Lack of Assurance of Sterility
- 2025-10-15GenoGenix LLCClass IIBacteriostatic 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
Lack of Assurance of Sterility
- 2025-10-15GenoGenix LLCClass IIB6 (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
Lack of Assurance of Sterility
- 2025-10-15GenoGenix LLCClass IIB5 Dexpanthenol for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
- 2025-10-15GenoGenix LLCClass IIB12 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.
Lack of Assurance of Sterility
- 2025-10-15GenoGenix LLCClass IIB12 Hydroxocobalamin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
- 2025-10-15GenoGenix LLCClass IIAscorbic Acid (Vitamin C) for Injection, Preserved, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
- 2025-10-15GenoGenix LLCClass IIAscorbic Acid (Vitamin C) for Injection, Preservative Free, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
- 2025-10-15GenoGenix LLCClass IIAmino Blend 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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