75 of 157 FDA warning letters naming a GLP‑1 came in the last 12 months

The FDA has published 157 warning letters whose text names a GLP-1 medication, the first in October 2023 and the most recent in September 2026.1 75 of them were issued in the last twelve months, against 74 in the twelve months before that — 1.0 times as many. 47.8% of every GLP-1 warning letter on record was issued in the last year.

The letters are not spread evenly across the months. In the last two years, September 2025 (61), February 2026 (31) and June 2026 (25) brought 117 of the 149 letters between them.1 The other months averaged 1.5 letters each. The FDA works through firms in coordinated sweeps, so a count between two dates depends on which sweeps fall inside the window.

110 of the 157 letters go to firms selling online rather than to manufacturers or traditional pharmacies, including 55 of the 75 issued in the last twelve months.1 The enforcement is aimed squarely at the direct-to-consumer channel. 12 letters went to recipients outside the United States.

Counted across the whole register, semaglutide appears in 149 letters, tirzepatide appears in 113 letters and liraglutide appears in 5 letters.1 The counts overlap, because a letter naming more than one molecule is counted under each. A letter enters this register when its text names a GLP-1, whatever else it alleges, so the counts show what the letters mention, not what they are mainly about.

2 of the 157 letters have a published closeout.1 That number says little about resolution. The FDA closes out a small minority of warning letters, and takes well over a year when it does. 47.8% of these letters are less than twelve months old, so "open" is the expected state of nearly all of them. An absent closeout is not a finding.

Among letters issued in the last twelve months, Florida received 14, California received 10 and New York received 7 — 31 of 75 between the three, spread across 19 states in total.1 These are the states with the most firms, not the states with the loosest rules. A letter goes to the company's registered address, which for an online seller need not be where anything is compounded or shipped from.

Names link to the page for that record where one is published.

We ingest the FDA's published warning letter list and keep every letter whose text names a GLP-1 molecule.1 The headline counts the letters issued in the last twelve months, measured from the day the page is read.

A letter is included on the strength of what the published letter says, not on what the firm sells. That is a wide net: it includes letters about an unrelated violation that mention a GLP-1.

Everything on this page counts letters, not firms. One company that received two letters appears twice. A warning letter is an allegation the agency has published and given the recipient a chance to answer. It is not a court finding.

1. A warning letter is an allegation the FDA has published. It is not a court finding.
2. A letter is included when its text names a GLP-1 molecule, whatever else it covers.
3. The FDA rarely publishes closeout letters and takes over a year on average when it does, so closeout status is shown per letter and never treated as a headline.