GLP-1 FDA Safety Alerts & Warnings: 2026 Tracker
FDA actions on GLP-1 medications that we have read at the source, with a link for each one. This is a selection, not a complete list. FDA's own pages are the record. Last checked November 6, 2026.
Correction, November 6, 2026: we rebuilt this page from FDA sources. Earlier versions listed events and rates we could not source, misdated the semaglutide shortage ending, and misstated the law on 503A and 503B compounding. Those are removed.
Dated Actions
FDA's adverse event counts for compounded GLP-1s
As of May 31, 2026, FDA had received 990 reports of adverse events associated with compounded semaglutide and more than 730 associated with compounded tirzepatide. FDA says it is not always possible to determine whether the event resulted from the drug. It also says state-licensed pharmacies that are not outsourcing facilities are not required to report, so events are likely underreported.
Source: FDA concerns page
Letter to Empower Pharmacy on tirzepatide and semaglutide combinations
FDA wrote that the products appear to be essentially copies of FDA-approved semaglutide and tirzepatide products, and that product volume suggests the differences are pretextual. A warning letter is FDA's stated position; it is not a court finding.
Source: FDA letter
What FDA tells telehealth companies about promoting compounded drugs
FDA flags describing a compounded drug as a generic version of an approved drug or the same as an approved drug, implying FDA approval or evaluation, claiming matching clinical results, claiming FDA-approved or FDA-licensed sourcing, and branding that suggests the telehealth company is the compounder.
Source: FDA to telehealth companies
FDA proposes to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list
FDA found no clinical need for outsourcing facilities to compound these drugs from bulk substances and asked for comments. It extended the comment period to July 30, 2026. This is a proposal. We found no final decision in the Federal Register as of November 6, 2026.
Letter to New Life Pharma on sterility
FDA cited a lack of the fundamental controls necessary to ensure sterility and identified the vials as unapproved new drugs. The letter notes the firm issued a voluntary recall of those vials in February 2026.
Source: FDA letter
FDA approves Foundayo (orforglipron)
A once-daily tablet approved to reduce excess body weight and maintain weight reduction long term in adults with obesity, or overweight with at least one weight-related condition. The labeling includes a boxed warning for thyroid C-cell tumors.
Source: FDA announcement
FDA restates 503A and 503B conditions for compounders
FDA spelled out when it considers a compounded product essentially a copy, including semaglutide combined with vitamin B12 at strengths within 10% of approved products, and said tirzepatide and semaglutide are not on the 503B bulks list or the shortage list.
Source: FDA policy page
FDA announces 30 warning letters to telehealth companies
FDA cited false or misleading claims on websites. Primary violations included claims implying sameness with FDA-approved products and branding that implied the telehealth company was the compounder.
Source: FDA announcement
FDA states its intent to act against non-FDA-approved GLP-1 drugs
The commissioner's statement announced an intent to restrict GLP-1 active pharmaceutical ingredients used in non-FDA-approved compounded drugs and to address misleading advertising.
Source: FDA statement
FDA asks manufacturers to remove the suicidal behavior and ideation warning
After a comprehensive review, FDA found no increased risk of suicidal ideation and behavior with GLP-1 receptor agonists and asked application holders to remove that information from labeling that includes it.
Source: FDA communication
FDA Letters to Firms Listed on This Site
These are the letters recorded on our provider pages. A letter states FDA's position on what it reviewed at that date, and a firm may have responded or changed since. Finding no letter here does not clear a firm, so search FDA's database.
- Eden, June 8, 2026
- Maximus, June 8, 2026
- MEDVi, February 20, 2026
- SkinnyRx, February 20, 2026
- Strut Health, February 20, 2026
- DirectMeds, September 9, 2025
- Hers, September 9, 2025
- Hims, September 9, 2025
- MyStart Health, September 9, 2025
- Sprout Health, September 9, 2025
- Zealthy, September 9, 2025
What FDA says about compounded semaglutide and tirzepatide
FDA and Federal Register pages read November 6, 2026.
- Not FDA-approved. FDA says compounded drugs are not FDA-approved, which means the agency does not review them for safety, effectiveness or quality before they are marketed. FDA, current as of October 1, 2026.
- Tirzepatide shortage. FDA determined the tirzepatide injection shortage was resolved on October 2, 2024. After litigation it re-evaluated and issued a new decision on December 19, 2024 that the shortage is resolved. FDA policy page.
- Semaglutide shortage. FDA determined the semaglutide injection shortage was resolved on February 21, 2025. FDA policy page.
- End of FDA's grace periods. After district courts denied preliminary injunctions on March 5, 2025 (tirzepatide) and April 24, 2025 (semaglutide), FDA said its period of enforcement discretion for section 503A compounders had ended. FDA policy page.
- Section 503A (state-licensed pharmacies and physicians). The drug must be compounded for an individual patient based on a prescription, and the compounder may not compound, regularly or in inordinate amounts, drugs that are essentially copies of a commercially available drug. FDA treats a product as essentially a copy unless a prescriber determines and documents a change that produces a significant difference for an identified patient. FDA says it does not intend, at this time, to act on that limit if a compounder fills four or fewer prescriptions of that product in a calendar month. FDA, April 1, 2026 update.
- Section 503B (outsourcing facilities).Outsourcing facilities are restricted from compounding with bulk drug substances unless the substance is on the 503B bulks list or the drug is on FDA's shortage list. FDA says tirzepatide and semaglutide are on neither. Section 503B also restricts making drugs that are essentially a copy of an FDA-approved drug. FDA policy page.
- 2026 proposal, not a final decision. On April 30, 2026, FDA proposed to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list, finding no clinical need. FDA announcement. It later extended the comment period to July 30, 2026. We found no final decision in the Federal Register as of November 6, 2026.
This describes FDA's public statements. It does not say whether any seller's product is lawful, and it is not legal advice. Ask the prescriber or seller which pharmacy makes your medicine and on what basis.
FDA-Approved GLP-1 Medicines
Common examples by active ingredient. Approved uses differ by product. This is not a complete list, so check Drugs@FDA. Compounded drugs are not FDA-approved.
| Semaglutide | Ozempic (injection and tablets), Rybelsus, Wegovy (injection and tablets) |
| Tirzepatide | Mounjaro, Zepbound |
| Orforglipron | Foundayo (tablets) |
| Liraglutide | Saxenda, Victoza |
| Dulaglutide | Trulicity |
What FDA Recommends
From FDA's concerns page. Talk to your prescriber before you change or stop any medicine.
Who compounded drugs are for
FDA says compounded drugs should only be used in patients whose medical needs cannot be met by an FDA-approved drug.
Where to fill a prescription
Get a prescription from your doctor and fill it at a state-licensed pharmacy. FDA's BeSafeRx campaign has resources for buying medicines online.
Telehealth red flags
FDA's list includes claims that a compounded drug is the same as an FDA-approved drug, prices that seem too good to be true, no screening or prescription by a licensed doctor, no doctor available afterward, and spelling errors or incorrect pharmacy addresses on the label.
Multi-dose vials
FDA recommends discarding a vial within 28 days after first use and using a new sterile needle and syringe for each dose.
Shipping
FDA recommends patients not use any injectable GLP-1 drug that arrives warm or with insufficient refrigeration.
Report problems
Report side effects and product problems to FDA MedWatch.
Official FDA Resources
Check a Provider
Use our scam checker on any GLP-1 provider, or see the listed providers with recorded prices, sources and any FDA letter we found.