GenoGenix LLC

FDA Regulatory Profile

Summary

Total Recalls
57 (1 Class I)
510(k) Clearances
0
Inspections
1
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0064-2026Class IIN-Acetyl-L-Cysteine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave July 30, 2025
D-0041-2026Class IIAscorbic Acid (Vitamin C) for Injection, Preserved, all strengths and presentations, GenoGenix, LLC,July 30, 2025
D-0042-2026Class IIB12 Hydroxocobalamin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd AveJuly 30, 2025
D-0083-2026Class IISemaglutide with B12 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd AveJuly 30, 2025
D-0085-2026Class IIBPC-157 for Injection, 15mg/10mL vial, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 BoJuly 30, 2025
D-0062-2026Class IIMagnesium Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave SJuly 30, 2025
D-0056-2026Class IIL-Arginine HCl for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 2July 30, 2025
D-0049-2026Class IICalcium Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave SteJuly 30, 2025
D-0093-2026Class IIRetatrutide for Injection, 60mg / 10mL vial, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste July 30, 2025
D-0088-2026Class IITesamorelin for Injection, 15mg, 10 mL Multi-Dose Vial, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 BocaJuly 30, 2025
D-0065-2026Class IINAD+ (Nicotinamide adenine dinucleotide), a) 50 mg/mL, b) 100 mg/mL, 10 mL multi-dose vials, all strJuly 30, 2025
D-0066-2026Class IITaurine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 BocaJuly 30, 2025
D-0079-2026Class IIProline for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 BocaJuly 30, 2025
D-0074-2026Class IIElite Stack MSC Exosome Reconstitution Solution for Injection, all strengths and presentations, GenoJuly 30, 2025
D-0043-2026Class IIB12 Methylcobalamin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave July 30, 2025
D-0089-2026Class IIEpithalon for Injection, 20mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca RatonJuly 30, 2025
D-0060-2026Class IILipo MIC +B12 Methylcobalamin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NJuly 30, 2025
D-0058-2026Class IIL-Glutamine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 July 30, 2025
D-0087-2026Class IIThymosin Beta-4 (TB4) for Injection, 15mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 20July 30, 2025
D-0068-2026Class IIUltra Burn for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 BJuly 30, 2025