GLP-1 Lawsuits & FDA Enforcement Tracker
3,797 total historical actions
110 total historical actions
The state of GLP-1 lawsuits and FDA enforcement keeps moving fast. As of the June 1, 2026 JPML statistics report, 3,763 cases are pending in MDL 3094 — the federal multidistrict litigation for gastrointestinal injuries from Ozempic, Wegovy, Mounjaro, and other GLP-1 drugs — and 110 cases are pending in MDL 3163, which covers vision-loss claims involving non-arteritic anterior ischemic optic neuropathy (NAION). One FDA proposal in the Federal Register would exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list if finalized, with a comment period closing June 30, 2026 per the Federal Register / Regulations.gov docket.
This page tracks all of it. It is built for reporters on deadline, financial analysts updating models, and compliance teams watching the regulatory line. We pull from public primary sources only — court dockets, FDA letters, Federal Register notices, SEC filings — and link the underlying document on every entry. There are no affiliate links, no plaintiff-intake forms, and no provider recommendations.
What is the current status of GLP-1 lawsuits and FDA enforcement?
| Tracker section | Current status | Last verified |
|---|---|---|
| MDL 3094 — GI injuries | Active 3,763 pending / 3,797 total historical actions; Judge Karen S. Marston, E.D. Pa.; latest public EDPA orders reviewed include Apr. 30, 2026 Amended CMO No. 12, Amended Scheduling Order, and CMO No. 32 | |
| MDL 3163 — NAION (vision loss) | Active 110 pending / 110 total historical actions; Judge Karen S. Marston, E.D. Pa.; Science Day was scheduled for June 2, 2026; later public EDPA orders include CMO No. 9, Apr. 30 Amended Scheduling Order, and CMO No. 10 | |
| FDA warning letters (compounded GLP-1) | Active / expanding March 3, 2026 sweep — 30 telehealth companies; FDA warning-letter database updated June 16, 2026 with additional letters; Reuters reported June batch as 25 warning letters | |
| 503B bulks list proposal | Proposed Federal Register notice May 1, 2026; Docket No. FDA-2018-N-3240; 91 FR 23431; Federal Register / Regulations.gov deadline June 30, 2026 | |
| Novo Nordisk v. Hims & Hers | Dismissed No. 1:26-cv-00143 (D. Del.); filed Feb 9, 2026; voluntarily dismissed without prejudice Mar 9, 2026; collaboration agreement announced | |
| OFA v. FDA (compounding challenges) | District-court rulings adverse to OFA — tirzepatide PI denied Mar. 5, 2025; tirzepatide summary judgment for defendants May 7, 2025; semaglutide PI denied Apr. 24, 2025; semaglutide summary judgment for FDA/Novo Jun. 13, 2025; final judgment Jun. 17, 2025; appeals should be tracked separately |
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 cases (Jun. 1, 2026) | 3,763 pending; 3,797 total historical actions Active |
| Pending cases (May 1, 2026) | 3,636 pending (superseded by June 1 report) |
| Pending cases (Apr. 1, 2026) | 3,546 pending; 3,580 total actions |
| Pending cases (Sep 2, 2025) | 2,676 |
| Pending cases (Aug 1, 2025) | 2,190 |
| Bellwether trial | Not located in public EDPA orders reviewed |
| Global settlement | None located in public EDPA orders reviewed |
Primary sources: EDPA MDL 3094 page · EDPA orders page · JPML pending statistics — May 1, 2026
What injuries does MDL 3094 cover?
The MDL covers gastrointestinal conditions plaintiffs allege were caused by GLP-1 drugs, with gastroparesis being the most frequently alleged.
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 | |
| Memorandum and order — diagnostic-proof requirements | Required plaintiffs claiming drug-induced gastroparesis to have a properly performed gastric emptying study (GES — scintigraphy, breath test, or wireless motility capsule) confirming delayed emptying at diagnosis | EDPA docket | |
| Memorandum on covered drugs | Notes parties' agreement that Victoza and Zepbound are properly included in MDL 3094 | EDPA docket | |
| JPML transfer order centralizing MDL 3163 | Created a separate NAION MDL; declined to fold NAION actions into MDL 3094 | JPML Doc. 49 | |
| 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 Rule 702 and summary-judgment briefing deadlines for cross-cutting issues 2 and 3; set Rule 702 hearing window for Sept. 10-18, 2026 | EDPA orders |
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 plaintiff count growth
Verified JPML monthly pending-action counts, pulled directly from JPML reports:
| JPML report date | Pending cases (MDL 3094) | Total actions (historical) |
|---|---|---|
| 2,190 | — | |
| 2,676 | — | |
| 2,809 | 2,843 | |
| 3,063 | 3,097 | |
| 3,546 | 3,580 | |
| 3,636 | — | |
| 3,763 | 3,797 |
Net change May 1 → June 1, 2026: +127 pending actions. Net change April 1 → June 1, 2026: +217 pending actions. Net change August 1, 2025 → June 1, 2026: +1,573 pending actions. The JPML series shows filings continued to increase after the August 15, 2025 diagnostic-proof order. We do not draw causal conclusions from that pattern.
What's next on the MDL 3094 docket
The court is in active case-management mode. Per the April 30, 2026 Amended Scheduling Order, status conferences are set for Jun. 23, Jul. 14, Oct. 13, Nov. 17, and Dec. 15, 2026. CMO No. 32 set a Rule 702 hearing window for cross-cutting issues 2 and 3 on Sept. 10-18, 2026. No bellwether trial was located in public EDPA orders reviewed June 17, 2026. We update this section within 48 hours of any major order.
GLP-1 Half-Life & Clearance Chart Understanding how long Ozempic, Wegovy, Mounjaro and other GLP-1s stay in your system — pharmacology relevant to injury timing in product-liability claims.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) |
| Drugs at issue | Ozempic, Wegovy, Saxenda (Novo Nordisk); Trulicity (Eli Lilly) |
| Defendants | Novo Nordisk and affiliates; Eli Lilly and Company |
| Pending cases (Jun. 1, 2026) | 110 pending; 110 total historical actions Active |
| Pending cases (May 1, 2026) | 86 (superseded by June 1 report) |
| Pending cases (Apr. 1, 2026) | 73 |
| Originating actions (Dec 2025) | 21 actions in three districts; nine related actions |
Primary sources: EDPA MDL 3163 page · EDPA orders page · JPML transfer order, December 15, 2025
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 (PRAC) recommended updating the 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 EMA action is one of the regulatory data points cited in MDL 3163 plaintiff filings.
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 Doc. 49 | |
| 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 |
"Science Day" is an early MDL proceeding where experts on each side present the underlying science to the judge before formal expert discovery begins. It is not a trial; it is an educational session for the court. CMO No. 6 scheduled Science Day for June 2, 2026 at 9:00 a.m. in Courtroom 16B. Because that date has passed, verify the docket or any public minute/order entry before stating whether Science Day occurred, was continued, or produced any public transcript or order.
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 cases (Jun. 1, 2026) | 3,763 | 110 |
| Defendants | Novo Nordisk, Eli Lilly | Novo Nordisk, Eli Lilly |
| Drugs | Ozempic, Wegovy, Rybelsus, Mounjaro, Zepbound, Trulicity, Saxenda, Victoza | Ozempic, Wegovy, Saxenda, Trulicity |
| Court / judge | E.D. Pa. / Marston | E.D. Pa. / Marston |
| Current status | Active discovery / case management; Rule 702 hearing window set for cross-cutting issues 2 and 3 in September 2026 | Early case management / discovery; Science Day was scheduled for June 2, 2026 and post-Science-Day docket status should be verified |
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 it had issued warning letters to 30 telehealth companies for illegal marketing of compounded GLP-1 medications. The agency cited claims implying the compounded products were the same as FDA-approved drugs, claims obscuring product sourcing, and other misleading representations about safety and efficacy.
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 | |
| / posted Jun. 16 | Telehealth GLP-1 companies — June batch | Telehealth / online sellers | Compounded GLP-1 marketing claims | Multiple | FDA warning-letter database; Reuters |
| Maximus Health | Telehealth / online seller | Compounded semaglutide and tirzepatide claims | MARCS-CMS 730095 | FDA letter |
We are populating individual letters from both the March 3, 2026 and June 16, 2026 posted telehealth batches as each letter is verified against FDA's warning-letter database. Each verified letter will receive its own deep anchor (e.g., #letter-id). Last checked: .
As of May 31, 2026, FDA had received 990 adverse-event reports related to compounded semaglutide and more than 730 related to compounded tirzepatide, per FDA's compounded GLP-1 safety page. FDA cautions that adverse-event reports do not always allow causality to be determined.
What is the status of the 503B bulks list proposal for semaglutide, tirzepatide, and liraglutide?
| Field | Detail |
|---|---|
| Status | Proposed — comment period open |
| 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 period closes | (per Federal Register notice) |
| Drugs at issue | Semaglutide, tirzepatide, liraglutide |
| FDA finding | "No clinical need" for outsourcing facilities to compound these drugs from bulk substances given that FDA-approved versions are available |
Primary sources: Federal Register notice 2026-08552 (91 FR 23431) · FDA press announcement, April 30, 2026
FDA's April 30, 2026 press announcement stated the comment deadline as "June 29, 2026," but the Federal Register notice itself (91 FR 23431) and Regulations.gov both show June 30, 2026. This tracker uses June 30, 2026 because the Federal Register is the authoritative source for regulatory comment periods.
On April 1, 2026, FDA clarified that semaglutide and tirzepatide do not currently appear on the 503B bulks list or FDA's drug shortage list. FDA's position is that, under Section 503B, outsourcing facilities generally may not compound drug products from bulk drug substances unless the substance appears on the 503B bulks list or the drug is on FDA's shortage list. The April 30 proposal would make this exclusion explicit and formal in the Federal Register.
Under Section 503A, state-licensed pharmacies may still compound patient-specific prescriptions with a documented, individualized clinical need — but cannot compound drugs that are "essentially a copy" of a commercially available FDA-approved product without that specific justification.
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 |
Sources: Court records via CourtListener/RECAP; FDA enforcement communications. We update this section as new rulings are issued.
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 | |
| Reason for dismissal | Collaboration agreement between parties |
| Hims obligations under agreement | Stop advertising compounded GLP-1 products; sell Novo-branded GLP-1s on platform |
| Carve-out | Hims said it would continue to offer compounded semaglutide on a limited scale when a provider determines it is clinically necessary |
| Novo reservation | Novo Nordisk reserved the right to refile |
Primary sources: D. Del. docket No. 1:26-cv-00143 · Hims & Hers investor announcement, March 9, 2026 · Hims & Hers 10-K (filed Feb. 23, 2026, SEC EDGAR) · Novo Nordisk company statement, February 9, 2026
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-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 EDGAR | |
| Novo Nordisk A/S | 20-F (FY 2025) | Form 20-F filed Feb. 4, 2026; compounding-environment disclosure verified. Verify the exact filing language before characterizing the specific MDLs named. | SEC EDGAR |
Reverse-chronological timeline of key events
| Date | Actor | Event | Source |
|---|---|---|---|
| FDA | FDA warning-letter database updated with additional telehealth GLP-1 warning letters dated Jun. 8, 2026; Reuters reported the June batch as 25 warning letters | FDA / Reuters | |
| FDA | FDA telehealth-compounding page identifies recurring false or misleading claim categories in compounded GLP-1 marketing | FDA | |
| Court | MDL 3163 Science Day scheduled for 9:00 a.m. in Courtroom 16B per CMO No. 6; verify docket before stating whether it occurred or was continued | EDPA | |
| JPML | JPML statistics report: MDL 3094 at 3,763 pending / 3,797 total historical actions; MDL 3163 at 110 pending / 110 total historical actions | JPML | |
| Court | MDL 3094: Amended CMO No. 12, Amended Scheduling Order (Jun.–Dec. 2026 conferences), and CMO No. 32 (Rule 702 hearing window Sept. 10-18) posted | EDPA | |
| Court | MDL 3163: Amended Scheduling Order and CMO No. 10 (ESI production) posted; CMO No. 9 (privilege logging) posted Apr. 29 | EDPA | |
| Federal Register | 503B bulks list proposal published; comment period opens (closes June 30, 2026 per Federal Register notice); 91 FR 23431; Docket No. FDA-2018-N-3240; Document No. 2026-08552 | Federal Register | |
| FDA | FDA proposes excluding semaglutide, tirzepatide, and liraglutide from the 503B bulks list | FDA | |
| FDA | FDA reminder on "essentially-a-copy" standard; confirms semaglutide and tirzepatide not on 503B bulks list or shortage list | FDA | |
| Court | MDL 3163 CMO Nos. 6 (Science Day), 7 (preservation), and 8 (Rule 502(d)) | EDPA | |
| Court / Corp | Novo voluntarily dismisses Hims lawsuit; collaboration announced; Hims stops advertising compounded GLP-1s; limited compounded semaglutide access continues when clinically necessary | Hims IR | |
| Court | MDL 3094 amended scheduling order — monthly status conferences for 2026 | EDPA | |
| FDA | FDA warns 30 telehealth companies in coordinated sweep (illegal marketing of compounded GLP-1s) | FDA | |
| SEC | Hims & Hers FY2025 10-K filed — discloses Novo lawsuit | SEC EDGAR | |
| FDA | FDA warning letter to MEDVi, LLC (MARCS-CMS 721455) for compounded semaglutide and tirzepatide marketing | FDA | |
| Court | Novo Nordisk files Novo Nordisk v. Hims & Hers, No. 1:26-cv-00143 (D. Del.) | D. Del. docket | |
| Court | MDL 3094 CMO No. 30 — streamlined docket procedures | EDPA | |
| Court | MDL 3163 CMO No. 1 — initial case management conference | EDPA | |
| JPML | JPML transfer order creates MDL 3163 (NAION) — 21 actions plus nine related; assigned to Judge Marston in E.D. Pa. | JPML Doc. 49 | |
| Court | MDL 3094 memorandum and order — gastroparesis plaintiffs must have gastric emptying study; Victoza and Zepbound confirmed in scope | EDPA docket | |
| Court | Summary judgment ruling in OFA v. FDA tirzepatide challenge | Court records | |
| JPML | JPML transfer order — adds Saxenda (liraglutide) cases to MDL 3094 | JPML | |
| JPML | JPML transfer order centralizes MDL 3094 in E.D. Pa.; initial assignment to Judge Pratter | JPML transfer 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?
3,763 cases pending as of the June 1, 2026 JPML Pending MDL Dockets by Actions Pending report, with 3,797 total historical actions. The May 1, 2026 report listed 3,636 pending; the April 1, 2026 report listed 3,546 pending. The count grew from 2,190 in August 2025. See the MDL 3094 section for the full verified series.
How many GLP-1 NAION lawsuits are pending in MDL 3163?
110 cases pending as of the June 1, 2026 JPML report, with 110 total historical actions. The May 1, 2026 report listed 86 pending. The MDL was created on December 15, 2025 by JPML transfer order (Doc. 49), initially consolidating 21 actions plus nine related actions. See the MDL 3163 section.
Who is the judge in the Ozempic MDL?
Hon. Karen S. Marston, U.S. District Court for the Eastern District of Pennsylvania. Judge Marston presides over both MDL 3094 (GI injuries) and MDL 3163 (NAION). MDL 3094 was initially assigned to Hon. Gene E.K. Pratter when it was centralized in February 2024.
What's the difference between MDL 3094 and MDL 3163?
MDL 3094 covers gastrointestinal injury claims (gastroparesis, ileus, bowel obstruction). MDL 3163 covers vision loss claims (NAION). They are separate proceedings with separate dockets, even though both are before Judge Marston in E.D. Pa. See the comparison table.
Is the Ozempic lawsuit a class action?
No. It is a multidistrict litigation (MDL), which is a federal procedural tool that consolidates many separate lawsuits before one judge for pretrial proceedings. Each individual case keeps its own identity. No global settlement or certified class was located in the public EDPA orders reviewed June 17, 2026.
Is there a GLP-1 lawsuit settlement yet?
No. No global settlement was located in the public EDPA orders reviewed June 17, 2026 for either MDL 3094 or MDL 3163. Both MDLs are in discovery and case-management phases.
Has a GLP-1 bellwether trial been scheduled?
No bellwether trial was located in the public EDPA orders reviewed June 17, 2026 for either MDL. MDL 3094 is in active discovery and case management; MDL 3163 had Science Day scheduled for June 2, 2026 and post-Science-Day orders should be verified separately.
Is compounded semaglutide still legal after the FDA shortage ended?
Compounded semaglutide remains legal in narrow circumstances. Under Section 503A, state-licensed pharmacies may compound patient-specific prescriptions, but they cannot compound drugs that are "essentially a copy" of a commercially available FDA-approved product unless there is a documented, individualized clinical need. Under Section 503B, outsourcing facilities cannot legally compound semaglutide from bulk drug substances unless the substance is on the 503B bulks list or the drug is on the FDA shortage list — neither is currently the case per FDA's April 1, 2026 update. See the 503B section.
What is the 503B bulks list?
The 503B bulks list is FDA's published list of bulk drug substances that registered outsourcing facilities (large-scale FDA-registered compounders) are allowed to compound from, based on a finding that there is a clinical need. Substances not on the list — and not on the FDA shortage list — generally cannot be compounded by 503B facilities from bulk active ingredient. See the 503B proposal section for current status.
Did Novo Nordisk drop the lawsuit against Hims?
Yes. Novo Nordisk filed Novo Nordisk A/S et al. v. Hims & Hers Health, Inc. et al., No. 1:26-cv-00143, on February 9, 2026 in D. Del., and voluntarily dismissed it without prejudice on March 9, 2026 as part of a collaboration agreement. Hims agreed to stop advertising compounded GLP-1 products and will sell Novo's branded GLP-1 medications on its platform. Hims also said it would continue to offer compounded semaglutide on a limited scale when a provider determines it is clinically necessary. Novo reserved the right to refile. See the full section.
What did the FDA propose on April 30, 2026?
The FDA proposed not to include semaglutide, tirzepatide, or liraglutide on the 503B bulks list, finding "no clinical need" for outsourcing facilities to compound these drugs from bulk substances given that FDA-approved versions are available. The Federal Register notice was published May 1, 2026 (Docket No. FDA-2018-N-3240; Document No. 2026-08552; 91 FR 23431); the public comment period closes June 30, 2026 per the Federal Register notice. See the 503B section.
What did the FDA do on March 3, 2026?
The FDA announced it had issued warning letters to 30 telehealth companies for illegal marketing of compounded GLP-1 medications. The agency cited claims implying sameness with FDA-approved drugs, claims obscuring product sourcing, and other misleading representations. See the warning letter section.
What did FDA announce on June 16, 2026?
FDA's warning-letter database was updated on June 16, 2026 with additional telehealth GLP-1 letters dated June 8, 2026. Reuters reported the June batch as 25 warning letters. One individually confirmed letter is to Maximus Health (MARCS-CMS 730095, dated June 8, 2026) for claims involving compounded semaglutide and tirzepatide. FDA has flagged the same categories of misleading claims it cited in the March 3, 2026 sweep. See the warning letters section.
How often is this tracker updated?
Monthly on the first of each month, plus within 48 hours of any major court order, FDA action, settlement, or 8-K filing (best effort). The "Last verified" timestamp at the top of the page reflects the most recent verification across all entries. The full revision history is in the change log.
Can I cite this tracker in my article or research note?
Yes. We encourage it. Use the recommended citation format and feel free to deep-link to specific entries via anchor URLs (e.g., #mdl-3094, #novo-v-hims, #bulks-list).
Do you provide legal, medical, or investment advice?
No. We are a research desk. Nothing on this page is legal advice, medical advice, 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.
Request the dataset
The full tracker is maintained as a structured dataset (date, category, entity, drug, brand, topic, source type, source ID, status, summary, primary source URL, last checked date, stable anchor). To request a copy for research, journalism, or compliance use, email [email protected].
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) | MDL 3094 and 3163 docket entries, case management orders, scheduling orders, hearing transcripts where public |
| CourtListener / RECAP | Free access to PACER docket entries; used to verify court filings and orders |
| FDA warning letter database | Letter ID, recipient, date issued, products, substantive allegations |
| FDA press announcements | Regulatory enforcement actions and policy changes |
| Federal Register | Proposed and final rules, comment periods |
| 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 (1st of each month): JPML pending statistics, EDPA orders pages, FDA warning letter database, FDA compounding policy page, Federal Register dockets, SEC filings, FDA Drug Shortages Database.
- Within 48 hours (best effort): any major court order, FDA action, settlement, or 8-K disclosure.
- Quarterly: dead-link audit on every primary source URL; replace with archive.org links if a source has moved, with a note in the change log.
Editorial independence
The RX Index research desk is the editorial group within The RX Index. 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 [email protected]. Corrections are reviewed on weekdays against court, FDA, SEC, or company primary sources, and logged in the change log after verification.
Change log
About this tracker
The RX Index research desk is the editorial group within The RX Index, an independent publisher covering GLP-1 medications and related healthcare topics. The research desk 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 the research desk. We are not lawyers and we are not doctors. If you spot something we got wrong, tell us.