How to report a problem with a compounded drug to FDA MedWatch

If a compounded drug makes you ill, arrives looking wrong, or comes with instructions that nearly led you to a wrong dose, there is a form for that, and it takes about fifteen minutes. This page is the short version of how to use it.

First, the people who can help you today

MedWatch is a reporting system, not an emergency service. If you are unwell, contact your prescriber, poison control (1-800-222-1222 in the US) or emergency services first. Then, in this order:

1. The pharmacy that dispensed it. They need the lot number and can quarantine the batch. A 503B outsourcing facility is required by law to report adverse events to FDA; a 503A pharmacy reports under state rules. Your call may be what triggers that.
2. The prescriber. For your own care, and because clinical detail from a health professional makes a MedWatch report far more useful.
3. Keep the vial, the packaging, the label and any paperwork. Photograph everything before it goes anywhere.

Which form

• Form FDA 3500B is the consumer version, written in plain language for patients and caregivers. Use it.
• Form FDA 3500 is the health professional version. Your prescriber or pharmacist can file it with clinical details; you may use it too.
• Online: the MedWatch voluntary reporting portal at accessdata.fda.gov/scripts/medwatch. It walks through the same questions as the paper form.
• Phone: 1-888-INFO-FDA (1-888-463-6332), press 2, to have a form sent or to ask how to report.
• Paper: download the PDF from FDA's reporting page and mail or fax it to the address printed on the form.

What to have ready

• Product name as printed on the label, concentration, and the lot number and beyond-use date.
• Pharmacy or outsourcing facility name and address from the label.
• Prescriber's name.
• What happened, when, and what you did. Dates and times help.
• The dose you took, how you measured it (syringe units, mL), and how the instructions were written. If the problem was a dosing error or a near-miss, say exactly what the label said and what you understood it to mean.
• Other medicines and conditions.
• Whether you want to be contacted. FDA rarely follows up, but you can ask.

What happens to the report

It enters FDA's adverse event reporting system, where it is used to look for patterns across many reports. That is how FDA arrived at the figures it publishes for compounded GLP-1s: 990 reports involving compounded semaglutide and more than 730 involving compounded tirzepatide as of May 31, 2026, many describing dosing errors. Reports are not proof that the drug caused the event, and FDA says so; they are the raw material for the warnings and, sometimes, the inspections on the enforcement timeline.

The state board, separately

FDA's report does not reach your state board of pharmacy. If the problem points at the pharmacy (a wrong concentration, contamination, a label with no lot number, a prescription that was never issued), file a complaint with the board of the state where the pharmacy is located and, if different, your own. Every board is linked on the all 50 boards page, and the how to verify a licence page explains what the boards can and cannot do.

If it was sold without a prescription or as "research"

Report it to MedWatch as above, and also through FDA's page for reporting unlawful sales of medical products on the internet, which the MedWatch page links to. Include the website address and screenshots. See salt forms and research use only for why that label matters.