FDA Issues Class I Recall for NAD+ Injection Due to Elevated Endotoxin Levels

The US Food and Drug Administration (FDA) has issued a Class I recall for NAD+ (Nicotinamide adenine dinucleotide) for Injection, available in 100 mg/mL and 200 mg/mL concentrations in 10 mL multi-dose amber vials, following the detection of elevated endotoxin levels—a serious microbial contamination issue. The affected product, manufactured and distributed by GenoGenix LLC, based in Boca Raton, Florida, involves Lot #GG121624-023, which remains within expiry. The voluntary recall was initiated on July 30, 2025, and affects distribution across the United States.

The FDA officially classified this recall as Class I on October 21, 2025, the most serious recall level, reserved for situations where use of the product may cause serious adverse health consequences or death. Elevated levels of endotoxins in injectable products can trigger severe inflammatory responses, including fever, shock, or even sepsis, particularly in vulnerable populations.

NAD+ injections are increasingly marketed and used for supporting cellular energy metabolism, neurological health, and anti-aging protocols, though their use remains largely unapproved for many indications by the FDA. In functional and integrative medicine settings, they are often administered intravenously. Pharmacists and health care providers should immediately stop distribution or administration of Lot #GG121624-023, verify inventory, and inform patients or clinicians of the potential contamination.

Reference

FDA. Enforcement Report. October 22, 2025. Accessed October 23, 2025. https://www.accessdata.fda.gov/scripts/ires/index.cfm