The FDA has sent 30 warning letters to telehealth companies over compounded GLP-1 products offered on their websites.
FDA officials have accused the companies of making false or misleading claims about compounded GLP-1 products and in one case identified manufacturing concerns that threatened the health of patients taking a non-GLP-1 compounded medicine. Three people were directed to the emergency room after taking products compounded by GenoGenix, according to the FDA’s warning letter.
Compounding pharmacies became a major source of GLP-1 medicines as patients struggled to access or afford branded products from Novo Nordisk and Eli Lilly in the early stages of the drugs’ launches. But the problem has persisted even as the supply was shored up and prices have come down. Novo estimated 1 million people were taking a compounded GLP-1 medicine last year and has repeatedly named the channel as a barrier to growth. The company has also raised doubts about the quality of compounded drugs, which are not reviewed premarket by the FDA.
The FDA has investigated the sector, sending warning letters to leading telehealth company Hims & Hers and its compounding pharmacy MedisourceRx in recent months. The agency continued the clampdown Tuesday, issuing 30 warning letters to smaller telehealth companies.
FDA officials alleged that some of the telehealth companies have implied that their goods are the same as approved medicines. The regulator also found companies have obscured product sourcing by advertising drugs branded with their name or trademark without qualification, implying they are the compounder.
In the case of GenoGenix, the FDA accused the compounder of repackaging semaglutide, tirzepatide and retatrutide. Semaglutide is the GLP-1 receptor agonist that Novo sells as Ozempic and Wegovy. Lilly sells the GLP-1/GIP drug tirzepatide as Mounjaro and Zepbound. Retatrutide is a next-generation GLP-1 medicine in development at Lilly.
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FDA inspectors found that, as well as repackaging GLP-1s, GenoGenix compounded medicines including 5-amino-1-methylquinolinium iodide (5-Amino-1MQ) and nicotinamide adenine dinucleotide (NAD+). 5-Amino-1MQ and NAD+ are ineligible for exemptions under section 503B, legislation that permits the compounding of medicines when there is a clinical need.
Further, the FDA found fault with manufacturing practices at GenoGenix’s facility. Inspectors found the company prepared, packed or held products in unsanitary conditions. The FDA said the conditions created the risk that the products “could be contaminated with filth or rendered injurious to health.”
Sure enough, the regulator documented three ER visits after patients taking a product containing NAD+ compounded by GenoGenix. The patients had low blood pressure, uncontrollable shaking, shivers and body aches. The FDA said an unopened vial from the same lot contained excessive bacterial endotoxins.
Operator errors were also a part of the problem as inspectors observed personnel failing to disinfect materials and engaging in aseptic processing while exposing skin. Other issues related to infrastructure. The FDA said the plant design could compromise the integrity of a cleanroom, potentially causing contamination. Inspectors also flagged violations related to establishing written procedures.