How to Report a Bad Kratom Product: FDA MedWatch, Poison Control and the Vendor
Step-by-step: get help first, keep the evidence, then report to the FDA, your state and the vendor. Here is what each channel is for and what to include.
Short answer: if anyone is hurt, get medical help first. Call 911 for an emergency, or Poison Help at 1-800-222-1222 for advice. Then keep the product and its packaging, and report the problem to the FDA through MedWatch or the FDA's online problem-report form. Tell the vendor too, and your state health department if your state regulates kratom. The FDA's kratom page specifically encourages consumers to report adverse reactions to MedWatch.
Reporting takes about 20 minutes and it matters. Regulators spot contaminated lots, mislabeled potency and dangerous "enhanced" products through reports like yours.
Step 1: Get help first
- Emergency (unresponsive, slow or stopped breathing, seizure, chest pain): call 911.
- Possible poisoning or a reaction you're unsure about: call Poison Help at 1-800-222-1222. It's free and answered 24/7, and it connects you to your local poison center.
- Symptoms that develop over days, such as yellowing skin or eyes, dark urine or severe stomach pain, need a doctor. The FDA lists liver toxicity among reported kratom adverse events.
Tell the clinicians exactly what was taken. Hand them the package if you can.
Step 2: Keep the evidence
Do this before you throw anything out or send anything back. A report with a lot number is far more useful than one without.
- The product itself. Seal what's left in a bag, label it with the date and keep it out of reach. Don't use any more of it.
- All packaging: outer box, pouch, bottle, label and any insert.
- Lot or batch number and any date codes. Photograph them clearly.
- The certificate of analysis (COA) for that lot. Download it or take a screenshot with the date showing, since vendor pages change. Our guide on how to read a kratom COA explains what to look for.
- Proof of purchase: order confirmation, receipt, store name and address, website URL.
- A short timeline: when it was bought, when it was used, what else was taken, when symptoms started, and what care was received.
- Medical paperwork, such as discharge summaries or test results, if you went to urgent care or an ER.
Step 3: Report to the FDA
The FDA's "Report a Problem" page lists the consumer routes:
| Route | Best for | Where |
|---|---|---|
| MedWatch / online problem report | Adverse reactions (you got sick) and product problems | FDA's online reporting form, linked from the MedWatch page |
| Form FDA 3500B | The consumer-friendly version of the MedWatch form, if you prefer a PDF | Downloadable from the FDA's Report a Problem page |
| Safety Reporting Portal | Problems with dietary supplements and human foods | safetyreporting.fda.gov (linked from the FDA kratom page) |
| FDA Consumer Complaint Coordinators | Talking to someone in your region by phone | Directory on the FDA's Report a Problem page |
The FDA's general line is 1-888-INFO-FDA (1-888-463-6332). Note that the FDA doesn't consider kratom a lawful supplement or food ingredient. Don't let that stop you, though. Report through whichever route fits what happened.
What to put in the report
- Brand, product name and format (powder, capsule, liquid extract, tablet).
- Lot number, size and where it was bought, with the website or store address.
- What happened, when, and how serious it was (ER visit, hospital stay).
- Everything else taken around the same time, including alcohol and prescriptions.
- Whether the label claimed things like "7-OH," "enhanced" or a specific alkaloid amount.
- That you still have the product and packaging, if you do.
You may not hear back about an individual report. Reports go into the FDA's safety monitoring, and patterns across reports are what lead to warnings and recalls.
Step 4: Report to your state
Many states now have kratom laws with age limits, labeling rules and caps on 7-OH. State agencies enforce those, not the FDA. Three examples, as of October 2026:
- Oklahoma: the state health department enforces the Kratom Consumer Protection Act (SB 891). In a July 2026 notice it asked consumers to use the OSDH Consumer Health Services Complaint Form. See our KCPA explainer for what these laws usually require.
- Kentucky: the Cabinet for Health and Family Services administers the state's kratom rules, and the Kentucky League of Cities lists state police, local police and prosecutors as enforcers too.
- Mississippi: a 2025 law (HB 1077) limits 7-OH and requires sellers to register with the Department of Revenue.
Elsewhere, start with your state health department or the attorney general's consumer-protection office. If a store sold to someone underage, or the product seems to break state limits, say so specifically.
Step 5: Tell the vendor (in writing)
Vendors can pull a bad lot faster than any agency. Contact them in writing so you have a record.
- Give the lot number and describe the problem briefly and factually.
- Ask whether they've had other reports on that lot and whether they'll test a retained sample.
- Ask for their return or refund process. Don't ship the product back until you've reported it and photographed everything. Our return-policy comparison shows how vendors differ.
- If they won't respond, or the website has no real contact details, that tells you something. See vendor website red flags.
A sample report you can adapt
Agencies get vague reports all the time. A clear, factual one stands out. Adapt this to your situation and keep it short:
"On [date], I bought [brand and product name, format, size] from [store name and address, or website]. Lot number [number], best-by [date]. The label states [alkaloid claims, if any]. On [date], about [time] after use, [person] developed [symptoms]. [He/she/I] [went to the ER / called Poison Help / saw a doctor] and [outcome]. Other substances taken that day: [list, including alcohol and prescriptions, or 'none']. I still have the remaining product, packaging and receipt. The vendor's COA for this lot [matches / does not match / could not be found]."
Use the same facts for the FDA, your state and the vendor. Consistent details across reports make it easier for anyone looking into the lot to connect them. Keep copies of everything you submit and note any confirmation or reference number you receive.
If the problem may involve mixing substances, our summary of what federal reports show about kratom and other drugs explains why investigators ask about everything else that was taken.
What counts as a "bad product"?
You don't need to be sure something was wrong to report it. Report if any of these apply:
- Someone had a reaction that needed medical attention.
- The product looks, smells or tastes different from previous lots, or shows mold or clumping.
- The lot number on the package doesn't match any COA the vendor will provide.
- The label claims an alkaloid content that the COA doesn't support.
- The product turned out to contain kratom without saying so. An FDA alert in May 2026 involved elixirs with undeclared mitragynine and mitragynine pseudoindoxyl.
- It's marketed as 7-OH or "enhanced," which federal and many state rules now target. See the adulterated kratom guide.
The FDA has not approved kratom for any use, there is no established safe dose, and anyone considering it should talk to a clinician first.
Sources
- FDA, "Report a Problem to the FDA": fda.gov
- FDA, MedWatch Safety Information and Adverse Event Reporting Program: fda.gov
- FDA, "FDA and Kratom" (updated December 2, 2025): fda.gov
- Poison Help (HRSA): poisonhelp.hrsa.gov
- Oklahoma Bureau of Narcotics and OSDH joint notice on SB 891 (July 13, 2026): obndd.ok.gov
- Kentucky League of Cities, "Kratom Regulations in Kentucky" (December 16, 2025): klc.org
- Mississippi HB 1077 (2025), as sent to the Governor: ls.state.ms.us
Before you buy: Kratom is not FDA-approved for any medical use, and there is no established safe dose. Regular use can lead to dependence, and stopping after regular use can cause withdrawal. Mixing kratom with alcohol, opioids, benzodiazepines, or other sedatives increases risk.
Talk to a doctor or pharmacist before use, especially if you take any medication. For confidential help with substance use, call the SAMHSA National Helpline at 1-800-662-4357 (free, 24/7).
Get help first (911 or Poison Help at 1-800-222-1222). Keep the product, packaging, lot number, COA and receipt. Report to the FDA through MedWatch or its online form, tell your state agency if your state regulates kratom, and notify the vendor in writing before returning anything.
Frequently Asked Questions
Where do I report a bad reaction to kratom?
Report it to the FDA through MedWatch or the FDA online problem-report form; the FDA kratom page encourages consumers to use MedWatch. For immediate advice, call Poison Help at 1-800-222-1222, and call 911 in an emergency.
Do I need the lot number to report?
No, but it makes the report far more useful. Photograph the lot or batch number and keep the packaging so regulators and the vendor can trace the specific batch.
Will the FDA contact me after I report?
Possibly not. Individual reports feed into the FDA safety monitoring, and patterns across reports are what lead to warnings and recalls.
Should I send the product back to the vendor?
Not until you have reported it and photographed everything. Keep the product and packaging as evidence, then ask the vendor about their return process in writing.
Can I report a store that sells kratom to minors?
Yes. In states with kratom age limits, report it to the state agency that enforces the kratom law, such as the health department, or to your attorney general consumer-protection office.