FDA · DrugsClass IClass IIOct 15, 2025

GenoGenix LLC drug recall: Alpha Lipoic Acid for Injection

Sterility concerns Microbial contamination

Key facts

Agency: U.S. Food and Drug Administration (FDA)
Program: Drugs
Classification: Class I, Class II
Status: Ongoing
Event ID: 97369
Recall initiated: Jul 30, 2025
Classified by FDA: Oct 21, 2025
Posted in Enforcement Report: Oct 15, 2025
Recalling firm: GenoGenix LLC
Firm location: Boca Raton, FL, United States
Initiated by: Voluntary: Firm initiated
Firm notified customers by: Letter
Products in this event: 57

What to do

Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.

View the official FDA record ↗

Reason for recall

Lack of Assurance of Sterility

Microbial Contamination of Sterile Products: elevated endotoxin levels

What the classification means

Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
Class II: Using or being exposed to the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.

About this recall

The firm started this recall on Jul 30, 2025. FDA classified it 83 days later, on Oct 21, 2025. This recall event covers 57 separate products, each with its own FDA recall number. Distribution reported by FDA: US Nationwide.

Recalled products (57)

D-0038-2026 Class II Ongoing

Alpha Lipoic Acid for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Codes / lots: All lots within expiry.
Quantity: 17
D-0039-2026 Class II Ongoing

Amino Blend for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692
Codes / lots: All lots within expiry.
Quantity: 235
D-0040-2026 Class II Ongoing

Ascorbic Acid (Vitamin C) for Injection, Preservative Free, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Codes / lots: All lots within expiry.
Quantity: 30
D-0041-2026 Class II Ongoing

Ascorbic Acid (Vitamin C) for Injection, Preserved, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Codes / lots: All lots within expiry.
Quantity: 1550
D-0042-2026 Class II Ongoing

B12 Hydroxocobalamin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Codes / lots: All lots within expiry.
Quantity: 25
D-0043-2026 Class II Ongoing

B12 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.
Codes / lots: All lots within expiry.
D-0044-2026 Class II Ongoing

B5 Dexpanthenol for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Codes / lots: All lots within expiry.
Quantity: 35
D-0045-2026 Class II Ongoing

B6 (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
Codes / lots: All lots within expiry.
D-0046-2026 Class II Ongoing

Bacteriostatic 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
Codes / lots: All lots within expiry.
D-0047-2026 Class II Ongoing

B-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.
Codes / lots: All lots within expiry.
D-0048-2026 Class II Ongoing

Biotin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Codes / lots: All lots within expiry.
Quantity: 296
D-0049-2026 Class II Ongoing

Calcium Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Codes / lots: All lots within expiry.
Quantity: 184
D-0050-2026 Class II Ongoing

GAC for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Codes / lots: All lots within expiry.
Quantity: 3
D-0051-2026 Class II Ongoing

GHK-Cu (Copper Peptide) for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Codes / lots: All lots within expiry.
Quantity: 221
D-0052-2026 Class II Ongoing

Glutathione 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.
Codes / lots: All lots within expiry.
D-0053-2026 Class II Ongoing

Glutathione Preserved for Injection, all strengths and presentations, GenoGenix LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692
Codes / lots: All lots within expiry.
Quantity: 907
D-0054-2026 Class II Ongoing

Glycine for Injection, all strengths and presentations, GenoGenix LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692
Codes / lots: All lots within expiry.
Quantity: 32
D-0055-2026 Class II Ongoing

L-Arginine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692
Codes / lots: All lots within expiry.
Quantity: 53
D-0056-2026 Class II Ongoing

L-Arginine HCl for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Codes / lots: All lots within expiry.
Quantity: 83
D-0057-2026 Class II Ongoing

L-Carnitine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692
Codes / lots: All lots within expiry.
Quantity: 161
D-0058-2026 Class II Ongoing

L-Glutamine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Codes / lots: All lots within expiry.
Quantity: 15
D-0059-2026 Class II Ongoing

Lipo MIC + L-Carnitine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Codes / lots: All lots within expiry.
Quantity: 172
D-0060-2026 Class II Ongoing

Lipo MIC +B12 Methylcobalamin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Codes / lots: All lots within expiry.
Quantity: 478
D-0061-2026 Class II Ongoing

Lysine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Codes / lots: All lots within expiry.
Quantity: 45
D-0062-2026 Class II Ongoing

Magnesium Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Codes / lots: All lots within expiry.
Quantity: 430
D-0063-2026 Class II Ongoing

Methylene Blue for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Codes / lots: All lots within expiry.
Quantity: 30
D-0064-2026 Class II Ongoing

N-Acetyl-L-Cysteine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Codes / lots: All lots within expiry.
Quantity: 85
D-0065-2026 Class II Ongoing

NAD+ (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
Codes / lots: All lots within expiry.
D-0066-2026 Class II Ongoing

Taurine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Codes / lots: All lots within expiry.
Quantity: 294
D-0067-2026 Class II Ongoing

Tri-Immune for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Codes / lots: All lots within expiry.
Quantity: 166
D-0068-2026 Class II Ongoing

Ultra Burn for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Codes / lots: All lots within expiry.
Quantity: 12
D-0069-2026 Class II Ongoing

Vitamin D3 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Codes / lots: All lots within expiry.
Quantity: 339
D-0070-2026 Class II Ongoing

Zinc Sulfate for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Codes / lots: All lots within expiry.
Quantity: 467
D-0071-2026 Class II Ongoing

Cerebrolysin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Codes / lots: All lots within expiry.
D-0072-2026 Class II Ongoing

CoQ10 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Codes / lots: All lots within expiry.
D-0073-2026 Class II Ongoing

EDTA for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Codes / lots: All lots within expiry.
D-0074-2026 Class II Ongoing

Elite Stack MSC Exosome Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Extension Health, a) 22 billion per vial, 8mL of solution in 10mL vial, b) 44 billion per vial, 8mL of solution in 10mL vial.
Codes / lots: All lots within expiry.
D-0075-2026 Class II Ongoing

Elite Stack Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Extension Health and Medical Health Institute (MHI).
Codes / lots: All lots within expiry.
D-0076-2026 Class II Ongoing

Low Solubility Peptide Reconstitution Solution 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.
Codes / lots: All lots within expiry.
D-0077-2026 Class II Ongoing

Oxytocin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Codes / lots: All lots within expiry.
D-0078-2026 Class II Ongoing

Pentosan for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Codes / lots: All lots within expiry.
D-0079-2026 Class II Ongoing

Proline for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Codes / lots: All lots within expiry.
D-0080-2026 Class II Ongoing

pH Buffered Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Medical Health Institute (MHI), 10mL.
Codes / lots: All lots within expiry.
D-0081-2026 Class II Ongoing

Reconstitution XO Solution 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 a) 5% Exosomes, 10 mL vial and b) 10% Exosomes, 5 mL vial, Extension Health a) 20% Exosomes, 10 mL vial, b) 10% Exosomes, 10 mL vial and Medical Health Institute (MHI), a) 10 % Exosomes, 2mL vial, 5mL vial, 10mL vial, b) 5% Exosomes, 2mL vial, 5mL vial, 10mL vial.
Codes / lots: All lots within expiry.
D-0082-2026 Class II Ongoing

Sterile Saline Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Codes / lots: All lots within expiry.
D-0083-2026 Class II Ongoing

Semaglutide with B12 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Codes / lots: All lots within expiry.
D-0084-2026 Class II Ongoing

Zinc Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Codes / lots: All lots within expiry.
D-0085-2026 Class II Ongoing

BPC-157 for Injection, 15mg/10mL vial, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Medical Health Institute (MHI), 15mg, 10mL vial lyophilized.
Codes / lots: Lot#: GG012825-002 within expiry.
D-0086-2026 Class II Ongoing

BPC-157/Thymosin Beta-4 for Injection, a) 10/10mg, b) 15/15mg, c) 15mg/15mg, all 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 (MHI).
Codes / lots: Lot#: GG020525-001, GG060525-001, GG062625-004, within expiry.
D-0087-2026 Class II Ongoing

Thymosin Beta-4 (TB4) for Injection, 15mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Codes / lots: Lot#: GG060525-001 within expiry.
D-0088-2026 Class II Ongoing

Tesamorelin for Injection, 15mg, 10 mL Multi-Dose Vial, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Codes / lots: Lot#: GG020425-004 within expiry.
D-0089-2026 Class II Ongoing

Epithalon for Injection, 20mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 manufactured for Extension Health.
Codes / lots: Lot#: GG053025-002 within expiry
D-0090-2026 Class II Ongoing

Sermorelin Lyophilized powder for reconstitution, 10mg, Vial capacity 10 mL Multi-Dose, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Codes / lots: Lot#: GG062425-002 within expiry.
D-0091-2026 Class II Ongoing

Semaglutide for Injection, a) 20 mg b) 20 mg/mL, 10 mL Multi-Dose Vials, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Synergy Wellness, 20 mg, 10mL vial lyophilized.
Codes / lots: Lot#: GG021125-001, GG031125-017, within expiry.
D-0092-2026 Class II Ongoing

Tirzepatide, 60mg/10 mL for Injection, 10mL vial lyophilized, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Extension Health and Synergy Wellness 60mg, 10mL vial lyophilized.
Codes / lots: Lots GG012925-005, GG021125-003, within expiry.
D-0093-2026 Class II Ongoing

Retatrutide for Injection, 60mg / 10mL vial, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692
Codes / lots: Lot#: GG021125-019, within expiry.
D-0094-2026 Class I Ongoing

NAD+ (Nicotinamide adenine dinucleotide) for Injection, a) 100 mg/mL b) 200 mg/mL, 10 mL multi-dose amber vials, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Codes / lots: Lot#: GG121624-023, within expiry

Source and freshness

Source: U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA drug enforcement dataset
Official notice: FDA Enforcement Report, event 97369
Raw record: openFDA API (JSON)
Dataset last updated by FDA: Nov 3, 2026
Imported by RecallRadar: Nov 4, 2026

Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.