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-0049-2026Class IICalcium Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave SteJuly 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-0060-2026Class IILipo MIC +B12 Methylcobalamin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NJuly 30, 2025
D-0057-2026Class IIL-Carnitine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 July 30, 2025
D-0061-2026Class IILysine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca July 30, 2025
D-0040-2026Class IIAscorbic Acid (Vitamin C) for Injection, Preservative Free, all strengths and presentations, GenoGenJuly 30, 2025
D-0041-2026Class IIAscorbic Acid (Vitamin C) for Injection, Preserved, all strengths and presentations, GenoGenix, LLC,July 30, 2025
D-0090-2026Class IISermorelin Lyophilized powder for reconstitution, 10mg, Vial capacity 10 mL Multi-Dose, GenoGenix, LJuly 30, 2025
D-0039-2026Class IIAmino Blend for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 July 30, 2025
D-0069-2026Class IIVitamin D3 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 BJuly 30, 2025
D-0091-2026Class IISemaglutide for Injection, a) 20 mg b) 20 mg/mL, 10 mL Multi-Dose Vials, GenoGenix, LLC, 2840 NW 2ndJuly 30, 2025
D-0094-2026Class INAD+ (Nicotinamide adenine dinucleotide) for Injection, a) 100 mg/mL b) 200 mg/mL, 10 mL multi-dose July 30, 2025
D-0050-2026Class IIGAC for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca RatJuly 30, 2025
D-0070-2026Class IIZinc Sulfate for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204July 30, 2025
D-0086-2026Class IIBPC-157/Thymosin Beta-4 for Injection, a) 10/10mg, b) 15/15mg, c) 15mg/15mg, all presentations, GenoJuly 30, 2025
D-0045-2026Class IIB6 (Pyridoxine HCl) for Injections, 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-0055-2026Class IIL-Arginine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 BJuly 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-0054-2026Class IIGlycine for Injection, all strengths and presentations, GenoGenix LLC, 2840 NW 2nd Ave Ste 204 Boca July 30, 2025