FDA Recall D-0094-2026

GenoGenix LLC · Boca Raton, FL

Class I — life-threatening Ongoing 288 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

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.

Lot / code: Lot#: GG121624-023, within expiry

Reason for recall

Microbial Contamination of Sterile Products: elevated endotoxin levels

Recall record

Recall number: D-0094-2026
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: US Nationwide.
Recall initiated: 2025-07-30
Classified by FDA Center: 2025-10-21
FDA published: 2025-10-15
Recalling firm: GenoGenix LLC
Firm location: Boca Raton, FL

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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