GLP-1 Lawsuits & FDA Enforcement Tracker
By Kaden Coziar, Founder & Managing Editor · The RX Index Research
4,056 total historical actions
216 total historical actions
As of the September 1, 2026 JPML report, 4,022 actions were pending in MDL 3094, involving gastrointestinal-injury claims, and 216 were pending in MDL 3163, involving NAION vision-loss claims. Both proceedings are before Judge Karen S. Marston in the Eastern District of Pennsylvania. The comment period on FDA's proposal not to include semaglutide, tirzepatide and liraglutide on the 503B bulks list closed July 30, 2026. The tirzepatide and semaglutide shortage-decision appeals were affirmed by the Fifth Circuit.
This page tracks selected public primary sources for reporters, analysts and compliance teams, including court orders, FDA letters, Federal Register notices, SEC filings and attributed company announcements. It is not a complete docket or a live enforcement database. Source documents or public orders indexes are linked where available. There are no affiliate links, plaintiff-intake forms or provider recommendations.
What is the current status of GLP-1 lawsuits and FDA enforcement?
| Tracker section | Current status | Sources checked |
|---|---|---|
| MDL 3094 — GI injuries | Active 4,022 pending / 4,056 total historical actions as of September 1; August 28 order rescheduled the Rule 702 hearing for September 14–18. Its occurrence or outcome was not established in the reviewed sources. | |
| MDL 3163 — NAION (vision loss) | Active 216 pending / 216 total historical actions as of September 1; July 2 CMO No. 12 directed early proceedings on general causation and preemption/warning adequacy. | |
| FDA warning letters (compounded GLP-1) | Selected individually linked February and June 8 marketing letters below; March 3 FDA announcement concerned 30 telehealth companies. Not an exhaustive count or finding that violations remain unresolved. | |
| 503B bulks list proposal | Proposed Original May 1 notice; extended July 30 comment deadline is closed. No final determination identified in the reviewed FDA/Federal Register sources. | |
| Novo Nordisk v. Hims & Hers | Dismissed without prejudice March 9, 2026; the Hims Q2 filing reports the dismissal. Separate from patient-injury MDL claims. | |
| OFA v. FDA (compounding challenges) | Fifth Circuit tirzepatide and semaglutide judgments affirmed August 27, 2026; semaglutide opinion revised September 1. Appeals 25-10600 and 25-10758. |
MDL is not a class action. Multidistrict litigation is a procedural tool that consolidates similar federal lawsuits before one judge for pretrial proceedings, with each individual case keeping its own identity.
Warning letters are not final determinations. FDA warning letters describe the agency's position at the time of issuance — matters may have been resolved through later interaction, response, or closeout.
Editorial reads are ours, not the court's. Anything labeled "editorial" is our reading of the verified facts above it, not a regulatory or judicial finding.
How many GLP-1 GI injury lawsuits are pending in MDL 3094?
| Field | Detail |
|---|---|
| MDL number | 3094 |
| Full title | In Re: Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RAs) Products Liability Litigation |
| Court | U.S. District Court for the Eastern District of Pennsylvania |
| Judge | Hon. Karen S. Marston (initially assigned to Hon. Gene E.K. Pratter at centralization) |
| Centralized | February 2, 2024 (JPML transfer order) |
| Drugs at issue | Original JPML order: Ozempic, Wegovy, Rybelsus, Trulicity, Mounjaro. Saxenda added Dec 12, 2024. Victoza and Zepbound included per Aug 15, 2025 memorandum. |
| Active substances | Semaglutide, tirzepatide, liraglutide, dulaglutide |
| Defendants | Novo Nordisk and affiliates; Eli Lilly and Company |
| Pending actions (Sep. 1, 2026) | 4,022 pending; 4,056 total historical actions JPML report |
| Bellwether trial date | Not identified in public EDPA orders reviewed September 25, 2026 |
| MDL-wide settlement | Not identified in public EDPA orders reviewed September 25, 2026 |
Primary sources: EDPA MDL 3094 public orders · JPML pending-action report — September 1, 2026. Historical counts are linked to their original reports below.
What injuries does MDL 3094 cover?
The claims include gastroparesis, ileus and bowel obstruction that plaintiffs allege were caused by GLP-1 drugs. Allegations are not findings of causation.
Gastroparesis is a condition where the stomach takes much longer than normal to empty, causing severe nausea, vomiting, abdominal pain, and weight loss. Ileus is when the intestines stop moving food normally, which can cause blockage. Bowel obstruction is a partial or complete blockage of the small or large intestine. All three can require hospitalization. Plaintiffs allege the labels for these drugs did not adequately warn about these risks at the time they were prescribed.
Key MDL 3094 rulings (running list)
| Date | Order / Event | What it did | Source |
|---|---|---|---|
| JPML transfer order centralizing MDL 3094 | Consolidated federal GLP-1 GI-injury cases in E.D. Pa.; initially assigned to Judge Pratter | JPML transfer order | |
| CMO No. 1 | Initial organizational conference | EDPA orders | |
| CMO No. 3 | Plaintiffs' steering committee structure | EDPA orders | |
| JPML transfer order adding Saxenda | Added liraglutide-product cases to MDL | JPML | |
| Order (Doc. 468) — gastroparesis diagnostic support | Requires a properly performed gastric-emptying study for a plaintiff claiming current or past gastroparesis; does not decide an individual's drug causation. The accompanying memorandum was not independently accessible in this review. | Mirror of court order; access may vary | |
| JPML transfer order centralizing MDL 3163 | Created a separate NAION MDL; declined to fold NAION actions into MDL 3094 | JPML transfer order | |
| CMO No. 30 | Streamlined docket procedures | EDPA orders | |
| Amended scheduling order | Set monthly status conferences for 2026 | EDPA orders | |
| Amended Case Management Order No. 12 — Plaintiff Fact Sheets | Updated plaintiff fact-sheet procedures | EDPA orders | |
| Amended Scheduling Order — 2026 Monthly Conferences | Cancelled May 12 and Dec. 8 status conferences; set status conferences for Jun. 23, Jul. 14, Oct. 13, Nov. 17, and Dec. 15, 2026 | EDPA orders | |
| Case Management Order No. 32 — Fifth Amended Scheduling Order for Cross-Cutting Issues 2 and 3 | Extended briefing deadlines for cross-cutting issues 2 and 3; initially set a September 10–18 Rule 702 hearing window, subsequently amended August 28 (see next order) | EDPA orders index | |
| Amended scheduling order, Doc. 881 | Rescheduled the Rule 702 hearing on cross-cutting issues 2 and 3 for September 14–18, 2026, in Courtroom 16B; this establishes a schedule, not the hearing's occurrence or outcome | EDPA order |
Before August 15, 2025, plaintiffs could allege drug-induced gastroparesis based on symptoms alone. After Judge Marston's order, they need an objective medical test — a gastric emptying study (GES), a breath test, or a wireless motility capsule study — that documented delayed gastric emptying at the time they were diagnosed. This is a meaningful evidentiary filter on which cases can move forward.
MDL 3094 pending-action history
Selected dated JPML reports. Pending actions are not unique people, proven injuries or new filings; months absent from this series have not been estimated.
| JPML report date | Pending actions (MDL 3094) | Total actions (historical) | Source |
|---|---|---|---|
| 2,190 | 2,193 | JPML report | |
| 2,676 | 2,710 | JPML report | |
| 2,809 | 2,843 | JPML report | |
| 3,063 | 3,097 | JPML report | |
| 3,546 | 3,580 | JPML report | |
| 3,636 | 3,670 | JPML report | |
| 3,763 | 3,797 | JPML report | |
| 3,848 | 3,882 | JPML report | |
| 3,928 | 3,962 | JPML report | |
| 4,022 | 4,056 | JPML report |
From June 1 to September 1, 2026, MDL 3094's pending-action count increased by 259 and MDL 3163's by 106. From August 3 to September 1, the respective net changes were 94 and 16. These are changes in pending actions, not counts of new filings or unique plaintiffs. The reports do not establish why the counts changed. June, August and September reports.
What's next on the MDL 3094 docket
The August 28 scheduling order set the Rule 702 hearing on cross-cutting issues 2 and 3 for September 14–18, replacing an earlier September 10–18 window. That was an expert-evidence hearing schedule, not a bellwether trial date. This review did not establish the hearing's occurrence or outcome or identify a resulting decision in the public orders reviewed. The April 30 conference schedule lists October 13, November 17 and December 15, 2026 at 1:00 p.m. in Courtroom 16B as the remaining scheduled status conferences.
GLP-1 Half-Life & Clearance Chart Pharmacology background on how long GLP-1 medicines remain in the body. Clearance estimates do not establish whether a drug caused an injury.How many GLP-1 NAION vision-loss lawsuits are pending in MDL 3163?
| Field | Detail |
|---|---|
| MDL number | 3163 |
| Full title | In Re: Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RAs) Non-Arteritic Anterior Ischemic Optic Neuropathy Products Liability Litigation |
| Court | U.S. District Court for the Eastern District of Pennsylvania |
| Judge | Hon. Karen S. Marston |
| Centralized | December 15, 2025 (JPML transfer order, Document 49) |
| Products identified in CMO No. 12 | Ozempic, Wegovy, Rybelsus, Saxenda, Trulicity, Mounjaro and Zepbound July 2 order |
| Defendants | Novo Nordisk and affiliates; Eli Lilly and Company |
| Pending actions (Sep. 1, 2026) | 216 pending; 216 total historical actions JPML report |
| Originating actions (Dec 2025) | 21 actions in three districts; nine related actions |
Primary sources: EDPA MDL 3163 orders · JPML December 2025 transfer order · JPML September 2026 report.
MDL 3163 pending-action history
Selected dated JPML reports, not an interpolated monthly series. Pending actions are not counts of unique people or proven injuries.
| Report date | Pending actions | Total historical actions | Source |
|---|---|---|---|
| 73 | 73 | JPML report | |
| 86 | 86 | JPML report | |
| 110 | 110 | JPML report | |
| 146 | 146 | JPML report | |
| 200 | 200 | JPML report | |
| 216 | 216 | JPML report |
What is NAION, in plain English?
NAION stands for non-arteritic anterior ischemic optic neuropathy. According to the American Academy of Ophthalmology, it is the most common acute optic neuropathy in adults over 50, caused by reduced blood flow to the front of the optic nerve. Damage typically causes painless, sudden vision loss in one eye — often noticed on waking — and the loss is frequently permanent. It is distinct from glaucoma, retinal detachment, or a stroke.
In June 2025, the European Medicines Agency's Pharmacovigilance Risk Assessment Committee recommended updating product information for semaglutide medicines — Ozempic, Rybelsus and Wegovy — to include NAION as a "very rare" side effect (up to 1 in 10,000 people). That regulatory action does not resolve the individual claims in MDL 3163.
MDL 3163 ruling and order timeline
| Date | Order / Event | What it did | Source |
|---|---|---|---|
| JPML Transfer Order centralizing MDL 3163 | Consolidated 21 NAION cases (plus nine related) before Judge Marston in E.D. Pa.; declined to fold them into MDL 3094 | JPML transfer order | |
| CMO No. 1 | Initial case management conference | EDPA orders | |
| CMO No. 2 | Procedures for pro hac vice admission | EDPA orders | |
| CMO No. 3 | Streamlined docket | EDPA orders | |
| CMO No. 4 | Direct filing order | EDPA orders | |
| CMO No. 5 | Plaintiffs' leadership counsel appointments | EDPA orders | |
| CMO No. 6 | Science Day procedures — scheduled for June 2, 2026 at 9:00 a.m. in Courtroom 16B | EDPA orders | |
| CMO No. 7 | Preservation order | EDPA orders | |
| CMO No. 8 | Rule 502(d) order (inadvertent disclosure of privileged material) | EDPA orders | |
| CMO No. 9 | Privilege logging order | EDPA orders | |
| Amended Scheduling Order — 2026 Monthly Conferences | Set 2026 monthly conference schedule; cancelled May 12 and Dec. 8 status conferences | EDPA orders | |
| CMO No. 10 | Defendants' production of electronically stored information (ESI) | EDPA orders | |
| CMO No. 11 | Qualified protective order and sealing process | EDPA order | |
| CMO No. 12 | Early discovery and motion practice on general causation and preemption/warning adequacy for seven named products; directs the parties to propose a schedule, but does not adopt their proposed dates as court-ordered deadlines | EDPA order |
"Science Day" is an educational proceeding for the court, not a trial. CMO No. 6 scheduled it for June 2, 2026 in Courtroom 16B. The reviewed materials establish the schedule, not whether it occurred or what resulted. See EDPA public orders.
How is MDL 3163 different from MDL 3094?
A common confusion: people refer to "the Ozempic lawsuit" as if it's one thing. There are two MDLs covering different injuries — same judge, same court, but different dockets, different evidence, and different scientific theories.
| Aspect | MDL 3094 | MDL 3163 |
|---|---|---|
| Injury type | Gastrointestinal (gastroparesis, ileus, bowel obstruction) | Vision loss (NAION) |
| Created | February 2, 2024 | December 15, 2025 |
| Pending actions (Sep. 1, 2026) | 4,022 JPML | 216 JPML |
| Defendants | Novo Nordisk, Eli Lilly | Novo Nordisk, Eli Lilly |
| Drugs | Ozempic, Wegovy, Rybelsus, Mounjaro, Zepbound, Trulicity, Saxenda, Victoza | Ozempic, Wegovy, Rybelsus, Saxenda, Trulicity, Mounjaro, Zepbound (July 2 CMO No. 12) |
| Court / judge | E.D. Pa. / Marston | E.D. Pa. / Marston |
| Current status | Case management; August 28 order scheduled Rule 702 hearing for September 14–18, 2026; outcome not established by reviewed sources | July 2 CMO No. 12 directed early discovery and motion practice on causation and preemption/warning adequacy |
Which FDA warning letters have been issued for compounded GLP-1 marketing?
March and June 2026 telehealth warning-letter waves
On March 3, 2026, FDA announced 30 telehealth-company warning letters over claims about compounded GLP-1 medications. The announcement date is distinct from individual letters' issue dates. The June entries below are selected June 8 letters, not a claimed batch total.
Primary source: FDA press announcement, March 3, 2026 — FDA Warns 30 Telehealth Companies Against Illegal Marketing of Compounded GLP-1s
Warning letter table (running)
| Date issued | Recipient | Type | Products at issue | MARCS-CMS / Letter ID | Primary source |
|---|---|---|---|---|---|
| MEDVi, LLC dba MEDVi | Telehealth / online seller | Compounded semaglutide and tirzepatide | 721455 | FDA letter | |
| 30 telehealth companies (batch) | Telehealth (coordinated sweep) | Compounded GLP-1 marketing claims | Multiple | FDA press release | |
| Altru Telehealth | Telehealth / online seller | Compounded semaglutide and tirzepatide claims | MARCS-CMS 728274 | FDA letter | |
| Momentum Health 360 | Telehealth / online seller | Compounded semaglutide, tirzepatide and liraglutide claims | MARCS-CMS 728286 | FDA letter | |
| Maximus Health | Telehealth / online seller | Compounded semaglutide and tirzepatide claims | MARCS-CMS 730095 | FDA letter |
Selected entries only; each named letter is linked to its individual FDA document. Sources checked: . A warning letter states the agency's concerns, not a court finding or a current-resolution status.
As of May 31, 2026, FDA reported 990 adverse-event reports associated with compounded semaglutide and more than 730 associated with compounded tirzepatide. FDA cautions that events may be underreported and that the reports do not always establish that the drug caused the event. These are reports, not incidence rates.
What is the status of the 503B bulks list proposal for semaglutide, tirzepatide, and liraglutide?
| Field | Detail |
|---|---|
| Status | Proposal; comments closed — no final determination identified in sources checked September 25, 2026 |
| FDA announcement | April 30, 2026 |
| Federal Register publication | May 1, 2026 |
| Federal Register docket | FDA-2018-N-3240 |
| Document number | 2026-08552 |
| Citation | 91 FR 23431 |
| Comment deadline | — extended from June 30 by the June 26 notice |
| Drugs at issue | Semaglutide, tirzepatide, liraglutide |
| FDA's proposed finding | FDA proposed that it had not identified a clinical need for these three substances on the 503B bulks list; the proposal is not a final adjudication |
Primary sources: May 1 Federal Register proposal (91 FR 23431) · June 26 extension (91 FR 38719) · FDA compounding policy clarification.
The May 1 notice originally set June 30, 2026; the later June 26 Federal Register notice extended the deadline to July 30, 2026. An earlier tracker version incorrectly used December 31. See the change log.
FDA's policy clarification describes separate 503B bulk-substance and shortage-list conditions, with other statutory requirements. The proposal concerns the bulks list; it should not be read as a new blanket ban on all compounding.
Under Section 503A, patient-specific prescriptions and limits on essentially copies of commercially available products apply; a prescriber-documented significant difference for an identified patient may matter. A prescription or a marketing claim of personalization alone does not prove compliance. See FDA's clarification.
OFA v. FDA: Legal challenges to compounded GLP-1 enforcement
| Date | Action | Result |
|---|---|---|
| OFA / FarmaKeio tirzepatide preliminary injunction or stay request | Denied | |
| OFA / FarmaKeio semaglutide preliminary injunction or stay request | Denied | |
| Tirzepatide summary-judgment ruling | Summary judgment granted for defendants; final judgment entered May 13, 2025; plaintiffs appealed | |
| Semaglutide summary-judgment ruling | Summary judgment granted in favor of the government and Novo Nordisk | |
| Semaglutide final judgment | Final judgment entered; plaintiffs appealed Jun. 18, 2025 | |
| Fifth Circuit tirzepatide appeal, No. 25-10600 | Judgment affirmed. Opinion | |
| Fifth Circuit semaglutide appeal, No. 25-10758 | Judgment affirmed; opinion revised September 1, 2026. Revised opinion |
Primary appellate sources: Fifth Circuit tirzepatide opinion · Fifth Circuit semaglutide opinion (revised September 1). Historical district-court entries are dated background, not the current appellate posture.
Novo Nordisk v. Hims & Hers: Filed, then dismissed
| Field | Detail |
|---|---|
| Case name | Novo Nordisk A/S et al. v. Hims & Hers Health, Inc. et al. |
| Case number | No. 1:26-cv-00143 (D. Del.) |
| Filed | |
| Status | Dismissed — voluntarily dismissed without prejudice |
| Dismissal date | |
| Filing disclosure | Hims Q2 Form 10-Q, filed August 10, 2026, confirms the dismissal and reserved right to refile |
Primary source for dismissal: Hims Q2 2026 SEC filing · filing index. Hims' March investor page was not independently accessible in this review, so operational terms of the collaboration are not asserted here.
Novo Nordisk's July 2026 advertising-lawsuit announcement
On July 21, 2026, Novo Nordisk announced that it had filed a separate lawsuit in the District of New Jersey against Eli Lilly and Lilly USA, challenging Zepbound and Mounjaro advertising as false or materially misleading. These are Novo's allegations in a company announcement, not judicial findings. No case number or disposition was established from the announcement reviewed here. This advertising dispute is distinct from MDL 3094, MDL 3163 and the Novo-Hims case.
SEC disclosures on GLP-1 litigation and enforcement
The following public company filings on SEC EDGAR contain material disclosures about GLP-1 litigation or regulatory enforcement that we track:
| Filing date | Issuer | Form | Disclosure | Source |
|---|---|---|---|---|
| Hims & Hers Health, Inc. | 10-Q (Q2 2026) | Reports Novo's March 9 dismissal without prejudice and that Hims was notified in February of a SEC staff investigation concerning certain compounded-semaglutide statements and business relationships; no wrongdoing finding is implied | SEC filing · filing index | |
| Hims & Hers Health, Inc. | 10-K (FY 2025) | Disclosed Novo Nordisk lawsuit (No. 1:26-cv-00143) and related regulatory risk from FDA enforcement actions on compounded GLP-1s | SEC 10-K | |
| Novo Nordisk A/S | 20-F (FY 2025) | Annual filing discusses the compounding environment; no specific MDL finding is attributed to this filing here. | SEC 20-F |
Reverse-chronological timeline of key events
| Date | Actor | Event | Source |
|---|---|---|---|
| JPML / Court | JPML reports 4,022 pending actions in MDL 3094 and 216 in MDL 3163; Fifth Circuit semaglutide opinion revised (judgment affirmed August 27) | JPML · Opinion | |
| Court | MDL 3094 order reschedules Rule 702 hearing to September 14–18; occurrence or outcome not established by the reviewed order | EDPA order | |
| Fifth Circuit | Affirms the two separate FDA shortage-decision appeals (tirzepatide No. 25-10600; semaglutide No. 25-10758) | Tirzepatide · Semaglutide | |
| SEC | Hims Q2 Form 10-Q filed, reporting March 9 Novo dismissal and a February notice of a SEC staff investigation | SEC filing | |
| JPML | MDL 3094: 3,928 pending actions; MDL 3163: 200 | JPML report | |
| Novo Nordisk | Company announces advertising lawsuit against Lilly over Zepbound and Mounjaro claims; allegations, not findings | Company release | |
| Court | MDL 3163 CMO No. 12 directs early discovery and motions on causation and preemption/warning adequacy for seven named products | EDPA order | |
| JPML | MDL 3094: 3,848 pending actions; MDL 3163: 146 | JPML report | |
| Federal Register | Extends the 503B proposal's comment deadline to July 30, 2026 (now closed) | Extension notice | |
| FDA | Issues selected letters to Altru Telehealth, Momentum Health 360 and Maximus Health; this is not an exhaustive list | Altru · Momentum · Maximus | |
| Court | MDL 3163 Science Day had been scheduled for this date; occurrence or outcome not established by the reviewed order | EDPA orders | |
| JPML | MDL 3094: 3,763 pending actions; MDL 3163: 110, historical report | JPML report | |
| Court | MDL 3163 CMO No. 11 establishes protective and sealing procedures | EDPA order | |
| Federal Register | Publishes 503B bulks-list proposal, later extended to a July 30 comment deadline | Proposal · Extension | |
| Court | MDL 3094 and 3163 case-management and scheduling orders posted; earlier Rule 702 schedule subsequently amended August 28 | MDL 3094 · MDL 3163 | |
| Hims filing | Novo voluntarily dismisses Hims patent case without prejudice; dismissal later disclosed in Q2 filing | SEC filing | |
| FDA | Letter to Novo concerns postmarketing adverse-drug-experience reporting procedures, not the telehealth marketing sweep | FDA letter | |
| FDA | Announces 30 telehealth-company warning letters about compounded GLP-1 marketing claims | FDA announcement | |
| FDA | MEDVi warning letter (MARCS-CMS 721455) about compounded semaglutide and tirzepatide marketing | FDA letter | |
| JPML | Transfer order centralizes MDL 3163 before Judge Marston | JPML order |
Frequently asked questions
Each answer below is written to stand on its own — short, neutral, primary-source-backed. Use them. They're built to be quoted.
How many GLP-1 lawsuits are pending in MDL 3094?
As of the September 1, 2026 JPML report, MDL 3094 had 4,022 pending actions and 4,056 total historical actions. These are federal MDL action counts, not all GLP-1 lawsuits nationwide or a count of unique injured people.
Sources: S01
How many GLP-1 NAION lawsuits are pending in MDL 3163?
As of the September 1, 2026 JPML report, MDL 3163 had 216 pending actions and 216 total historical actions.
Sources: S01
Who is the judge in the Ozempic MDL?
What's the difference between MDL 3094 and MDL 3163?
Is the Ozempic lawsuit a class action?
Is there a GLP-1 lawsuit settlement yet?
Has a GLP-1 bellwether trial been scheduled?
Is compounded semaglutide still legal after the FDA shortage ended?
Some compounding may qualify under statutory exceptions, but the end of the shortage changes the available pathways. Section 503A includes patient-specific requirements and restrictions on essentially copies; a prescriber-documented significant difference for an identified patient can matter. Section 503B has separate bulk-substance and shortage-list conditions. A prescription or a marketing claim of personalization does not by itself establish that every legal condition has been met.
Sources: S20
What is the 503B bulks list?
It is FDA's list of bulk drug substances for which the agency has identified a clinical need for use by outsourcing facilities under Section 503B. A separate shortage-list pathway exists, and other statutory conditions apply. FDA's May 2026 proposal concerned not including semaglutide, tirzepatide and liraglutide on the bulks list.
Did Novo Nordisk drop the lawsuit against Hims?
What did the FDA propose on April 30, 2026?
FDA announced a proposal not to include semaglutide, tirzepatide or liraglutide on the 503B bulks list. The notice was published May 1. Its original June 30 comment deadline was extended to July 30, 2026, and that period is closed. No final determination was identified in the FDA/Federal Register sources reviewed September 25.
What did the FDA do on March 3, 2026?
FDA announced warning letters to 30 telehealth companies concerning illegal marketing of compounded GLP-1 products. The announcement date is distinct from each letter's issuance date, and a warning letter is not a final judicial finding.
Sources: S24
Which June 2026 FDA warning letters are verified here?
How often is this tracker updated?
The research editor reviews the tracker monthly after the JPML report and adds material developments after verification. Source dates and the scope of each review are shown separately from the page's update date. The revision history is recorded in the change log.
Can I cite this tracker in my article or research note?
Yes. Cite Kaden Coziar, the tracker title, the displayed update date, your access date and the canonical URL. Use an entry's stable anchor for a specific event, and cite the linked primary document when quoting a court, regulator or company.
Do you provide legal, medical, or investment advice?
No. This is a research publication, not personalized legal, medical or investment advice. If you have a potential GLP-1 injury claim, talk to a lawyer. If you have health concerns related to a GLP-1 medication, talk to your doctor.
How to cite this tracker
Recommended citation
For deep-link citations, append the entry anchor — for example: #mdl-3094, #novo-v-hims, #bulks-list, #fda-warning-letters.
Methodology, sources, and corrections
What we include
| Source | What we pull |
|---|---|
| JPML | Pending action counts (monthly reports), transfer orders, reassignments |
| Eastern District of Pennsylvania (EDPA) | Public MDL 3094 and 3163 orders, case-management and scheduling orders; no complete PACER review is implied |
| FDA warning letter database | Letter ID, recipient, date issued, products, substantive allegations |
| FDA press announcements | Regulatory enforcement actions and policy changes |
| Federal Register | Proposal and extension notices; searches through September 25 found no subsequent final determination for this proposal, but this does not establish that no action exists elsewhere |
| SEC EDGAR | 10-K, 10-Q, 8-K, 20-F filings disclosing GLP-1 litigation matters |
| Company statements | Press releases and investor relations announcements directly issued by parties |
What we exclude
We do not include unsourced settlement projections, plaintiff-intake material from law firms without primary-source backing, "who qualifies" legal-advice content, speculative medical claims about causation not adopted by a court or regulatory agency, anonymous social media claims as evidence of fact, or market-status claims sourced only to secondary reporting.
Update cadence
- Monthly: Review published JPML pending-action reports and material EDPA, FDA, Federal Register and SEC updates after their release.
- As verified: Add material developments with their source dates. A missed or inaccessible document is not a finding that no event occurred.
- Source access: Link the underlying public document where accessible and label source indexes or attributed company statements separately.
Editorial independence
The RX Index Research is the research section of The RX Index, edited by Kaden Coziar. The rest of The RX Index earns affiliate commissions on consumer-facing pages. Nothing on /research/ carries affiliate links, plaintiff-intake forms, or commercial CTAs. We do not accept payment from any party — plaintiffs, defendants, manufacturers, telehealth platforms, compounders, law firms, or trade associations — for placement, omission, or characterization of any entry on this tracker.
Corrections
If we got something wrong — a wrong date, a wrong case number, a wrong characterization of an order — send the correction with a primary-source link to hello@therxindex.com. Corrections are reviewed on weekdays against court, FDA, SEC, or company primary sources, and logged in the change log after verification.
Change log
Related research
- Compounded GLP-1 Enforcement Tracker Regulatory actions concerning compounded GLP-1 products.
- Counterfeit GLP-1 Incidents Tracker Regulator notices and reported counterfeit incidents.
- GLP-1 FDA Label Changes Documented changes to approved product labeling.
- Compounded GLP-1 Laws by State State rules and federal compounding distinctions.
About this tracker
The RX Index Research is the research section of The RX Index, an independent publisher covering GLP-1 medications and related healthcare topics. It is edited by Kaden Coziar and operates separately from the consumer-facing side of the site: there are no affiliate links, no plaintiff-intake forms, and no commercial CTAs anywhere on /research/.
This tracker is a working document maintained by Kaden Coziar. We are not lawyers and we are not doctors. If you spot something we got wrong, tell us.