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-0064-2026, Class II) was initiated on July 30, 2025.

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-0065-2026Class IINAD+ (Nicotinamide adenine dinucleotide), a) 50 mg/mL, b) 100 mg/mL, 10 mL multi-dose vials, all strJuly 30, 2025
D-0079-2026Class IIProline for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 BocaJuly 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-0087-2026Class IIThymosin Beta-4 (TB4) for Injection, 15mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 20July 30, 2025
D-0040-2026Class IIAscorbic Acid (Vitamin C) for Injection, Preservative Free, all strengths and presentations, GenoGenJuly 30, 2025
D-0090-2026Class IISermorelin Lyophilized powder for reconstitution, 10mg, Vial capacity 10 mL Multi-Dose, GenoGenix, LJuly 30, 2025
D-0082-2026Class IISterile Saline Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLJuly 30, 2025
D-0066-2026Class IITaurine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 BocaJuly 30, 2025
D-0038-2026Class IIAlpha Lipoic Acid for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave StJuly 30, 2025
D-0074-2026Class IIElite Stack MSC Exosome Reconstitution Solution for Injection, all strengths and presentations, GenoJuly 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-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-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-0041-2026Class IIAscorbic Acid (Vitamin C) for Injection, Preserved, all strengths and presentations, GenoGenix, LLC,July 30, 2025