76 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 76 of them were issued in the last twelve months, against 73 in the twelve months before that — 1.0 times as many. 48.4% of every GLP-1 warning letter on record was issued in the last year.

The letters are not spread evenly across the months. September 2025 alone accounts for 61 of them, and February 2026 for another 31.1 Between those spikes the register runs at one or two letters a month. That shape matters for anyone quoting the count: this is the FDA working through a cohort of firms in coordinated sweeps, so the trend line between two arbitrary dates says more about which sweeps fall inside the window than about any change in underlying conduct.

110 of the 157 letters go to firms selling online rather than to manufacturers or traditional pharmacies, including 55 of the 76 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, which is the FDA reaching offshore sellers shipping into it.

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 published text names a GLP-1 at all, whatever else it alleges, so the molecule counts describe what the letters mention rather than what they are principally about.

2 of the 157 letters have a published closeout.1 That number is close to meaningless as a measure of resolution, and we publish it here only so that nobody else reads it as one: the FDA closes out a small minority of warning letters in general, and takes well over a year to do it when it does. Given that 48.4% of these letters are less than twelve months old, "open" is the expected state of nearly all of them, and this page does not treat an absent closeout as a finding.

Among letters issued in the last twelve months, Florida received 15, California received 10 and New York received 7 — 32 of 76 between the three, spread across 27 states in total.1 These are the states with the most firms in the channel, not the states with the loosest rules; a warning letter is addressed to a company's registered address, which for an online seller need not be where anything is compounded or shipped from.

The complete list, so the count can be checked rather than taken on trust. 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 count in the headline is the number of those letters with an issue date inside the last twelve months, measured from the day the page is rebuilt rather than from a fixed date, so the window moves with the reader.

A letter is included on the strength of what the published letter says, not on what the firm sells. That is a deliberately wide net: it catches letters about an unrelated violation that happen to mention a GLP-1, and we would rather include those and say so than curate the register by hand.

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, and no page here treats it as one.

Each of these changes what the figure means. They are numbered so a quotation can name the one it breaks.

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.