FDA has sent 32 warning letters on GLP-1 drugs and peptides since December 2024
The tally covers three kinds of targets, and the August letters shift the legal argument from how a product was described to whether it can be sold at all.
The FDA has issued 32 warning letters touching GLP-1 medicines and research peptides since December 2024, according to a register of the letters counted on 12 September 2026 [1]. The earliest carries a date of 10 December 2024; the most recent, 24 August 2026 [1].
The register sorts recipients into three groups: 17 telehealth or compounding businesses, 12 sellers of research peptides, and three letters addressed to the manufacturers of the approved drugs themselves [1]. That sorting reflects the register's reading of each letter, not an FDA classification; the agency does not group its enforcement correspondence this way [1].
The letters arrive in bursts on single dates rather than one at a time, and the targets appear to alternate — peptide sellers, then telehealth, then peptide sellers again [1]. Five other letters went out individually between December 2025 and January 2026 and sit outside those clusters [1].
The largest single batch was 13 letters dated 8 June 2026, addressed to NativeMed, HydraMed, Harper Meds, AM RX, Altru Telehealth, Maximus, altRx, Mint Med, Ezra, DrMedHealth, D&H Medical Services, Amie and Momentum Health [1].
Three of the 32 went to Eli Lilly and Novo Nordisk, which make Ozempic and Wegovy (semaglutide) and Mounjaro and Zepbound (tirzepatide) [1]. Two arrived on 9 September 2025, one per company, and Novo Nordisk received another on 5 March 2026 [1].
The August letters make a different argument
Five letters dated 24 August 2026 went to Peptide Partners LLC, Peak Performance Peptides, Royal Peptides LLC, NuScience Peptides LLC, and TXP Innovations LLC, which also uses the name Tex Peptides [2]. The FDA posted all five on 1 September 2026 after reviewing each company's website in July 2026 [2].
These letters describe injectable semaglutide, tirzepatide, retatrutide, tesamorelin, elamipretide (SS-31) and bremelanotide (PT-141) sold under "research use only" labels, and treat the products as unapproved new drugs under sections 301(d) and 505(a) of the Food, Drug, and Cosmetic Act [2]. Earlier compounder letters challenged how compounded GLP-1 products were described; the August letters say the products cannot be sold at all [1]. The register describes those as two enforcement tracks running side by side [1].
Why it matters for patients
A warning letter records a finding about conduct — most often about promotion — and the agency sends them to the largest manufacturers in the category as readily as to a small online shop [1]. It is not a statement about whether a drug works [1].
Nor does the tally say much about what is inside any vial. The letters describe no testing, and the great majority allege no contamination, potency failure, or patient harm [1]. The number of sellers is unknown, so 32 counts enforcement actions rather than market size [1]. A letter also opens a process without recording how it ends; the register does not show whether a company corrected the problem, closed, or ignored it [1]. The register is filtered to the molecules its publisher covers, so a letter about a different compound would not appear [1].
Compounding of the approved drugs has narrowed separately. On 27 August 2026 the Fifth Circuit upheld their removal from the drug shortage list, ending bulk 503B compounding of semaglutide and tirzepatide for general use; patient-specific 503A compounding for someone with a documented medical need remains lawful [2].
What happens next
The five sellers named on 24 August 2026 have a 15-business-day response window, after which the FDA could seek seizure or an injunction [2]. Novo Nordisk asked the agency on 19 August 2026 to place semaglutide on the Demonstrable Difficulties for Compounding lists, a request first filed in October 2024 that remains pending [2].
Peptides that the Pharmacy Compounding Advisory Committee recommended for the 503A Bulks List on 24 July 2026 are not lawfully compoundable today; that vote is advisory and formal rulemaking can take up to a year [2]. Dr. Heidi Overton, nominated to lead the FDA on 19 August 2026, has made no public statements on peptide compounding or GLP-1 policy, and no confirmation hearing has been set [2].
The counts above were taken on 12 September 2026 and will change as more letters are published [1].
Sources
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