GenoGenix LLC

FDA Regulatory Profile

GenoGenix LLC appears in FDA public data with 57 recalls — including 1 Class I (most serious) —, 0 510(k) clearances, 1 FDA inspection, and 1 compliance action on record. Its most recent recall (D-0084-2026, Class II) was initiated on Jul 30, 2025.

Summary

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

Recent Recalls

NumberClassProductDate
D-0084-2026Class IIZinc Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 20Jul 30, 2025
D-0079-2026Class IIProline for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 BocaJul 30, 2025
D-0090-2026Class IISermorelin Lyophilized powder for reconstitution, 10mg, Vial capacity 10 mL Multi-Dose, GenoGenix, LJul 30, 2025
D-0059-2026Class IILipo MIC + L-Carnitine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd AJul 30, 2025
D-0088-2026Class IITesamorelin for Injection, 15mg, 10 mL Multi-Dose Vial, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 BocaJul 30, 2025
D-0082-2026Class IISterile Saline Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLJul 30, 2025
D-0039-2026Class IIAmino Blend for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Jul 30, 2025
D-0038-2026Class IIAlpha Lipoic Acid for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave StJul 30, 2025
D-0053-2026Class IIGlutathione Preserved for Injection, all strengths and presentations, GenoGenix LLC, 2840 NW 2nd AveJul 30, 2025
D-0083-2026Class IISemaglutide with B12 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd AveJul 30, 2025
D-0055-2026Class IIL-Arginine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 BJul 30, 2025
D-0042-2026Class IIB12 Hydroxocobalamin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd AveJul 30, 2025
D-0045-2026Class IIB6 (Pyridoxine HCl) for Injections, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd AveJul 30, 2025
D-0064-2026Class IIN-Acetyl-L-Cysteine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Jul 30, 2025
D-0065-2026Class IINAD+ (Nicotinamide adenine dinucleotide), a) 50 mg/mL, b) 100 mg/mL, 10 mL multi-dose vials, all strJul 30, 2025
D-0066-2026Class IITaurine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 BocaJul 30, 2025
D-0057-2026Class IIL-Carnitine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Jul 30, 2025
D-0061-2026Class IILysine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Jul 30, 2025
D-0046-2026Class IIBacteriostatic Water for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd AveJul 30, 2025
D-0058-2026Class IIL-Glutamine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Jul 30, 2025