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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

GenoGenix Injectable Products Recalled for Sterility and Endotoxin Risks

Agency Publication Date: October 21, 2025
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Summary

GenoGenix LLC is recalling 6,365 units of various injectable medications, including Vitamin B12, Semaglutide, and NAD+, because they may not be sterile or may contain elevated levels of endotoxins (microbial contaminants). The recall affects a wide range of injectable solutions and powders, including products labeled for CELIA Health, Extension Health, Medical Health Institute, and Synergy Wellness. Consumers should stop using these products immediately as they were distributed nationwide across the United States.

Risk

Injecting a product that is not sterile or contains high levels of endotoxins can lead to serious and life-threatening infections or severe inflammatory reactions. No injuries have been reported to date, but the microbial contamination poses a significant health risk to patients receiving these injections.

What You Should Do

  1. Identify if you have any affected GenoGenix injectable products by checking the product name and brand on the vial or outer packaging. See the Affected Products section below for the full list of affected codes.
  2. Check for lot numbers GG012825-002, GG020525-001, GG060525-001, GG062625-004, GG020425-004, GG053025-002, GG062425-002, GG021125-001, GG031125-017, GG012925-005, GG021125-003, GG021125-019, or GG121624-023; all other listed products are recalled for all lots within their expiry date.
  3. Stop using the recalled product immediately.
  4. Contact the manufacturer or your distributor to arrange for the return of the products.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Bacteriostatic Water for Injection
Lot Numbers:
All lots within expiry
NDC:
D-0046-2026

Also labeled as manufactured for CELIA Health, Extension Health and Medical Health Institute

Product: B-Complex for Injection
Lot Numbers:
All lots within expiry
NDC:
D-0047-2026

B-Complex with B12 also labeled as manufactured for Synergy Wellness.

Product: Biotin for Injection
Lot Numbers:
All lots within expiry
NDC:
D-0048-2026
Product: Calcium Chloride for Injection
Lot Numbers:
All lots within expiry
NDC:
D-0049-2026
Product: GAC for Injection
Lot Numbers:
All lots within expiry
NDC:
D-0050-2026
Product: GHK-Cu (Copper Peptide) for Injection
Lot Numbers:
All lots within expiry
NDC:
D-0051-2026
Product: Glutathione Magnesium for Injection
Lot Numbers:
All lots within expiry
NDC:
D-0052-2026

Also labeled as manufactured for CELIA Health.

Product: Glutathione Preserved for Injection
Lot Numbers:
All lots within expiry
NDC:
D-0053-2026
Product: Glycine for Injection
Lot Numbers:
All lots within expiry
NDC:
D-0054-2026
Product: L-Arginine for Injection
Lot Numbers:
All lots within expiry
NDC:
D-0055-2026
Product: L-Arginine HCl for Injection
Lot Numbers:
All lots within expiry
NDC:
D-0056-2026
Product: L-Carnitine for Injection
Lot Numbers:
All lots within expiry
NDC:
D-0057-2026
Product: L-Glutamine for Injection
Lot Numbers:
All lots within expiry
NDC:
D-0058-2026
Product: Lipo MIC + L-Carnitine for Injection
Lot Numbers:
All lots within expiry
NDC:
D-0059-2026
Product: Lipo MIC +B12 Methylcobalamin for Injection
Lot Numbers:
All lots within expiry
NDC:
D-0060-2026
Product: Lysine for Injection
Lot Numbers:
All lots within expiry
NDC:
D-0061-2026
Product: Magnesium Chloride for Injection
Lot Numbers:
All lots within expiry
NDC:
D-0062-2026
Product: Methylene Blue for Injection
Lot Numbers:
All lots within expiry
NDC:
D-0063-2026
Product: N-Acetyl-L-Cysteine for Injection
Lot Numbers:
All lots within expiry
NDC:
D-0064-2026
Product: NAD+ (Nicotinamide adenine dinucleotide)
Variants: 50 mg/mL, 100 mg/mL, 10 mL multi-dose vials
Lot Numbers:
All lots within expiry
NDC:
D-0065-2026

Also labeled as manufactured for CELIA Health

Product: Taurine for Injection
Lot Numbers:
All lots within expiry
NDC:
D-0066-2026
Product: Tri-Immune for Injection
Lot Numbers:
All lots within expiry
NDC:
D-0067-2026
Product: Ultra Burn for Injection
Lot Numbers:
All lots within expiry
NDC:
D-0068-2026
Product: Vitamin D3 for Injection
Lot Numbers:
All lots within expiry
NDC:
D-0069-2026
Product: Zinc Sulfate for Injection
Lot Numbers:
All lots within expiry
NDC:
D-0070-2026
Product: Cerebrolysin for Injection
Lot Numbers:
All lots within expiry
NDC:
D-0071-2026
Product: CoQ10 for Injection
Lot Numbers:
All lots within expiry
NDC:
D-0072-2026
Product: EDTA for Injection
Lot Numbers:
All lots within expiry
NDC:
D-0073-2026
Product: Elite Stack MSC Exosome Reconstitution Solution for Injection
Variants: 22 billion per vial, 44 billion per vial, 8mL solution, 10mL vial
Lot Numbers:
All lots within expiry
NDC:
D-0074-2026

Also labeled as manufactured for Extension Health

Product: Elite Stack Reconstitution Solution for Injection
Lot Numbers:
All lots within expiry
NDC:
D-0075-2026

Also labeled as manufactured for Extension Health and Medical Health Institute (MHI).

Product: Low Solubility Peptide Reconstitution Solution for Injection
Lot Numbers:
All lots within expiry
NDC:
D-0076-2026

Also labeled as manufactured for CELIA Health.

Product: Oxytocin for Injection
Lot Numbers:
All lots within expiry
NDC:
D-0077-2026
Product: Pentosan for Injection
Lot Numbers:
All lots within expiry
NDC:
D-0078-2026
Product: Proline for Injection
Lot Numbers:
All lots within expiry
NDC:
D-0079-2026
Product: pH Buffered Reconstitution Solution for Injection
Variants: 10mL
Lot Numbers:
All lots within expiry
NDC:
D-0080-2026

Also labeled as manufactured for Medical Health Institute (MHI)

Product: B6 (Pyridoxine HCl) for Injections
Lot Numbers:
All lots within expiry
NDC:
D-0045-2026

Also labeled as manufactured for Synergy Wellness

Product: Alpha Lipoic Acid for Injection
Lot Numbers:
All lots within expiry
NDC:
D-0038-2026
Product: Amino Blend for Injection
Lot Numbers:
All lots within expiry
NDC:
D-0039-2026
Product: Ascorbic Acid (Vitamin C) for Injection, Preservative Free
Variants: Preservative Free
Lot Numbers:
All lots within expiry
NDC:
D-0040-2026
Product: Ascorbic Acid (Vitamin C) for Injection, Preserved
Variants: Preserved
Lot Numbers:
All lots within expiry
NDC:
D-0041-2026
Product: B12 Hydroxocobalamin for Injection
Lot Numbers:
All lots within expiry
NDC:
D-0042-2026
Product: B12 Methylcobalamin for Injection
Lot Numbers:
All lots within expiry
NDC:
D-0043-2026

Also labeled as, manufactured for Synergy Wellness.

Product: B5 Dexpanthenol for Injection
Lot Numbers:
All lots within expiry
NDC:
D-0044-2026
Product: Reconstitution XO Solution for Injection
Variants: 5% Exosomes, 10% Exosomes, 20% Exosomes
Lot Numbers:
All lots within expiry
NDC:
D-0081-2026

Labeled for CELIA Health, Extension Health, and Medical Health Institute (MHI).

Product: Sterile Saline Reconstitution Solution for Injection
Lot Numbers:
All lots within expiry
NDC:
D-0082-2026
Product: Semaglutide with B12 for Injection
Lot Numbers:
All lots within expiry
NDC:
D-0083-2026
Product: Zinc Chloride for Injection
Lot Numbers:
All lots within expiry
NDC:
D-0084-2026
Product: BPC-157 for Injection (15mg/10mL)
Variants: 15mg/10mL vial, lyophilized
Lot Numbers:
GG012825-002
NDC:
D-0085-2026

Also labeled as manufactured for Medical Health Institute (MHI)

Product: BPC-157/Thymosin Beta-4 for Injection
Variants: 10/10mg, 15/15mg
Lot Numbers:
GG020525-001
GG060525-001
GG062625-004
NDC:
D-0086-2026

Also labeled as manufactured for CELIA Health, Extension Health and Medical Health Institute (MHI).

Product: Thymosin Beta-4 (TB4) for Injection (15mg)
Variants: 15mg
Lot Numbers:
GG060525-001
NDC:
D-0087-2026
Product: Tesamorelin for Injection (15mg)
Variants: 15mg, 10 mL Multi-Dose Vial
Lot Numbers:
GG020425-004
NDC:
D-0088-2026
Product: Epithalon for Injection (20mg)
Variants: 20mg
Lot Numbers:
GG053025-002
NDC:
D-0089-2026

manufactured for Extension Health.

Product: Sermorelin Lyophilized powder for reconstitution (10mg)
Variants: 10mg, 10 mL Multi-Dose
Lot Numbers:
GG062425-002
NDC:
D-0090-2026
Product: Semaglutide for Injection (20mg)
Variants: 20 mg, 20 mg/mL, 10 mL Multi-Dose Vials, lyophilized
Lot Numbers:
GG021125-001
GG031125-017
NDC:
D-0091-2026

Also labeled as manufactured for Synergy Wellness

Product: Tirzepatide for Injection (60mg/10 mL)
Variants: 60mg/10 mL, lyophilized
Lot Numbers:
GG012925-005
GG021125-003
NDC:
D-0092-2026

Also labeled as manufactured for Extension Health and Synergy Wellness

Product: Retatrutide for Injection (60mg/10mL)
Variants: 60mg / 10mL vial
Lot Numbers:
GG021125-019
NDC:
D-0093-2026
Product: NAD+ (Nicotinamide adenine dinucleotide) (Amber Vials)
Variants: 100 mg/mL, 200 mg/mL, 10 mL multi-dose amber vials
Lot Numbers:
GG121624-023
NDC:
D-0094-2026

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97369
Status: Active
Manufacturer: GenoGenix LLC
Sold By: CELIA Health; Extension Health; Medical Health Institute; Synergy Wellness
Manufactured In: United States
Units Affected: 27 products (17; 235; 30; 1550; 25; 35; 296; 184; 3; 221; 907; 32; 53; 83; 161; 15; 172; 478; 45; 430; 30; 85; 294; 166; 12; 339; 467)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.