CLASS I ONGOING Drug recall · Reported 15 Oct 2025 · FDA Enforcement Report
NAD+ (Nicotinamide adenine dinucleotide) for Injection recalled
GenoGenix is recalling NAD+ (Nicotinamide adenine dinucleotide) for Injection, a) 100 mg/mL b) 200 mg/mL, distributed nationwide in the US. The recall was initiated on 30 Jul 2025 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0094-2026
- FDA event ID
- 97369
- Recalling firm
- GenoGenix, Boca Raton, FL
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 30 Jul 2025
- FDA classified
- 21 Oct 2025
- Reported
- 15 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 30 Jul 2025 | Recall initiated by company | |
| 15 Oct 2025 | Published in enforcement report | +77 days |
| 21 Oct 2025 | Classified by FDA | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Microbial Contamination of Sterile Products: elevated endotoxin levels
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide.
Questions about this recall
Why was it recalled?
Microbial Contamination of Sterile Products: elevated endotoxin levels
Which lots are affected?
Lot#: GG121624-023, within expiry
Where was it sold?
US Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
56 other products · FDA event 97369This product is part of a recall event; the main page for the event is Reconstitution XO Solution for Injection, all strengths recalled.
More recalls from GenoGenix
All 57| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ultra Burn for Injection, all strengths and presentations recalled | GenoGenix | Sterility | Nationwide |
| Drug | CLASS II | Semaglutide with B12 for Injection, all strengths recalled by GenoGenix | GenoGenix | Sterility | Nationwide |
| Drug | CLASS II | Sterile Saline Reconstitution Solution for Injection recalled | GenoGenix | Sterility | Nationwide |
| Drug | CLASS II | B6 (Pyridoxine HCl) for Injections, all strengths recalled by GenoGenix | GenoGenix | Sterility | Nationwide |
| Drug | CLASS II | Sermorelin Lyophilized powder for reconstitution, 10mg recalled | GenoGenix | Sterility | Nationwide |
Other Nad+ (nicotinamide Adenine Dinucleotide recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | NAD+ (Nicotinamide adenine dinucleotide), a) 50 mg/mL recalled | GenoGenix | Sterility | Nationwide |
| Drug | CLASS II | NAD+ Nicotinamide Adenine Dinucleotide recalled | Olympia Compounding Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | NAD+ Nicotinamide Adenine Dinucleotide recalled | Olympia Compounding Pharmacy | Other | Nationwide |