Recalls / Class I
Class ID-0094-2026
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
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.
- Affected lot / code info
- Lot#: GG121624-023, within expiry
Why it was recalled
Microbial Contamination of Sterile Products: elevated endotoxin levels
Recalling firm
- Firm
- GenoGenix LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2840 Nw 2nd Ave Ste 204, Boca Raton, Florida 33431-6692
Distribution
- Distribution pattern
- US Nationwide.
Timeline
- Recall initiated
- 2025-07-30
- FDA classified
- 2025-10-21
- Posted by FDA
- 2025-10-15
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0094-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.