NAD+ (Nicotinamide adenine dinucleotide) for Injection, a) 100 mg/mL b) 200 mg/mL, 10 mL multi-dose amber vials, GenoGen
Summary
The FDA issued a Class I for NAD+ (Nicotinamide adenine dinucleotide) for Injection, a) 100 mg/mL b) 200 mg/m by GenoGenix LLC. Reason: Microbial Contamination of Sterile Products: elevated endotoxin levels.
Details
Source
Drug Recall
External ID
D-0094-2026
Action Date
2025-10-15
Status
Ongoing
Category
drug
Product Description
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 Info: Lot#: GG121624-023, within expiry
Reason for Recall
Microbial Contamination of Sterile Products: elevated endotoxin levels
Distribution
US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-07-30
Company
Boca Raton, FL
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 92 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
GenoGenix LLC has 57 FDA actions in our database, including 57 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (GenoGenix LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does GenoGenix LLC have FDA actions?
GenoGenix LLC has 57 FDA actions in our database, including 57 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0094-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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