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In the United States, report a suspected counterfeit or contaminated medicine to the FDA’s MedWatch program as a product problem. If you suspect deliberate criminal counterfeiting, make a separate report through the FDA Office of Criminal Investigations. If the medicine came from an unlawful online seller, report the website, account, or seller through the FDA’s unsafe-online-pharmacy or unlawful-medical-product-sales route. If anyone took the medicine or has symptoms, contact a healthcare professional promptly; medical care comes before regulatory reporting.
First, deal with the health risk
A report to a regulator does not replace medical advice. If you or another person swallowed, injected, inhaled, or otherwise used the suspect medicine, contact a pharmacist, doctor, poison-information service, or other qualified healthcare professional promptly. Tell them that the product may be counterfeit or contaminated, and provide the package if it is safe to do so.
Do not take another dose of a suspect product while waiting for advice. Do not taste, smell, dilute, open, or perform a home test on it. If the product has already been used, note the amount and time as accurately as possible. Seek emergency medical care for severe or rapidly worsening symptoms, trouble breathing, loss of consciousness, seizures, or another immediately dangerous condition.
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Keep the medicine, outer box, blister pack, bottle, leaflet, shipping material, and purchase records if doing so is safe and practical. Place them somewhere children and pets cannot reach. Packaging and remaining product can help a regulator and a clinician identify what was sold, but do not delay urgent care to collect it.
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Choose the reporting route that matches what happened
U.S. agencies use different channels for different parts of a suspected medicine problem. A product-quality report, a report of possible criminal activity, and a report about an unlawful seller are related but not interchangeable.
| Situation | Primary U.S. route | What the route addresses | Useful information |
|---|---|---|---|
| You suspect the medicine is counterfeit, contaminated, defective, or otherwise not what its label says | FDA MedWatch | Product problems, including suspected counterfeit product and suspected contamination | Product name, labeled strength, manufacturer or labeler, NDC number when present, lot number when available, purchase source, dates, observations, and any symptoms |
| You believe the suspected counterfeit activity may be criminal | FDA Office of Criminal Investigations | Suspected criminal counterfeit activity | Seller and transaction details, product and package identifiers, communications, payment records, and a description of why the activity appears deliberate or unlawful |
| A website, social-media account, or other seller appears to be selling medicines unlawfully or operating an unsafe online pharmacy | FDA route for unlawful medical-product sales or potentially unsafe online pharmacies | The seller, website, account, or sales operation | Web address or account name, screenshots, advertisements, order details, contact information, payment records, and the medicine’s identifying details |
| You are outside the United States | Your National Medicines Regulatory Authority, with help from a pharmacist or doctor | The regulator responsible for medicines in your country | Product and package details, purchase source, dates, what you observed, and any suspected reaction |
One incident may justify more than one report. For example, a medicine bought from an online seller can be reported to MedWatch as a product problem and separately reported through the FDA’s unlawful-sales route. If the evidence points to criminal counterfeit activity, the Office of Criminal Investigations route addresses that separate concern.
How to file a U.S. MedWatch report
FDA treats suspected counterfeit medicine and suspected contamination as product-quality problems. MedWatch accepts reports from consumers as well as healthcare professionals. Use the current FDA MedWatch reporting channel and Form FDA 3500 instructions; you do not have to prove the product is counterfeit before reporting a reasonable suspicion.
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1Fix the driver behind crashes, sound loss and screen glitches2Clear out junk files and repair common Windows errors3Scan for outdated or missing drivers - takes under a minute- Confirm the immediate safety step. If the product was used or anyone feels unwell, contact a healthcare professional first. Record whether the product was taken, how much was used if known, and when.
- Identify the product from the label. Copy the exact product name, labeled strength, dosage form, manufacturer or labeler, NDC number if printed, and lot number if available. Photographing the label can reduce transcription errors, but retain the original package too.
- Describe the product problem. Explain what made you suspect a problem: an unexpected appearance, unusual packaging, a different smell, a change in how the medicine worked, an unusual side effect, suspected contamination, or another discrepancy. Describe observations rather than declaring an unverified conclusion.
- Record the source and timing. State where you obtained it, such as a pharmacy, clinic, website, social account, marketplace, or person; when you ordered or received it; and when you first noticed the concern. Include the seller’s name and contact details when known.
- Report any adverse event separately within the same report. Give the symptoms, when they began, how long they lasted, treatment received, and whether the person recovered. FDA’s Form 3500 instructions say to select both the product-problem and adverse-event categories when a product problem may have caused or contributed to an adverse event.
- Submit the information you have. Missing a lot number or another field should not prevent filing. FDA identifies manufacturer or labeler, labeled strength, NDC number, and lot number as especially useful, but not every detail is mandatory before a report can be made.
“To report, it is not necessary to be certain of a cause/effect relationship between the adverse event and the use of the medical product(s) in question.” — U.S. Food and Drug Administration, Instructions for Completing Form FDA 3500
This means you may report a suspected adverse event even when you cannot establish that the medicine caused it. Give the facts and your level of uncertainty; do not wait for laboratory confirmation.
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What information to gather before reporting
Make a short incident record while details are fresh. A clear chronology is often more useful than a long theory about what happened.
Product identifiers
- Exact name as printed on the package
- Labeled strength and dosage form, such as tablet, capsule, liquid, cream, or injection
- Manufacturer, labeler, or distributor name
- NDC number, if the package carries one
- Lot or batch number and expiration date, when shown
- Quantity purchased and quantity remaining
Purchase and distribution details
- Name and physical location of the pharmacy, clinic, website, account, or other source
- Web address, account handle, telephone number, email address, or other contact information when relevant
- Order number, invoice, receipt, shipping label, and payment record
- Date ordered, date received, and date opened or used
- Whether the product was prescribed, supplied by a healthcare facility, or obtained without a prescription
What you observed
- Differences in color, shape, markings, seal, label, spelling, or package design
- Unexpected odor, leakage, particles, cloudiness, broken tablets, or other visible changes
- Whether the medicine appeared to work differently than expected
- Unusual side effects or a suspected adverse reaction
- Any mismatch between the package, the order, and what was delivered
Describe what you saw, smelled, or experienced without treating appearance alone as proof. FDA lists appearance differences, unusual side effects, and online purchase as possible warning signs, not conclusive evidence that a product is counterfeit or contaminated.
When to add the FDA criminal-counterfeit report
Use the FDA Office of Criminal Investigations route when your concern involves suspected criminal counterfeit activity. Examples include a seller deliberately presenting a product as an authentic medicine, repeated use of false labels, or an organized operation offering supposedly genuine medicines that appear to be fake. You do not need to investigate or prove intent yourself. State the facts that led you to suspect criminal activity and let investigators assess them.
Include copies or photographs of advertisements, chats, invoices, shipping labels, and payment confirmations when they can be shared safely. Preserve the original files and note the date each item was captured. Do not confront a seller, arrange another purchase, or put yourself at risk to obtain more evidence.
When to report an unlawful online seller
If the concern is the website, social-media account, marketplace listing, or other seller, use the FDA route for unsafe online pharmacies or unlawful medical-product sales. This report focuses on the sales operation rather than replacing the product-quality report.
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Record the exact web address or account name, the date and time you viewed the listing, the claims made in the advertisement, the price and quantity offered, and how the seller handled prescriptions or medical questions. Save screenshots that show the seller’s identity and the listing, because online content can change. Include the order and delivery details if you purchased anything.
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How to describe suspected contamination or a counterfeit product
Separate observation from interpretation
Use wording such as “the liquid contained visible particles,” “the seal was broken on arrival,” or “the tablet markings differed from the package photograph.” Then explain that these observations led you to suspect contamination or counterfeiting. This gives the regulator testable facts without overstating what you know.
Include a timeline
List when the product was purchased, received, opened, and used; when the unusual feature was noticed; and when any symptom began. If several people used the same package, identify which person used it and what each person experienced.
Explain what is unknown
If the lot number is missing, the seller is anonymous, or the amount taken is uncertain, say so. An incomplete report can still alert FDA to a possible product problem. Do not fill gaps with guesses.
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What not to do with a suspect medicine
- Do not taste, sniff deliberately, or apply the product to yourself to “test” it.
- Do not continue taking it solely to see whether symptoms return.
- Do not discard the package before recording its identifiers, unless keeping it creates a safety hazard.
- Do not alter the tablets, liquid, labels, or container.
- Do not send a sample to an unverified person or company that promises a result.
- Do not assume a normal appearance proves authenticity or safety.
If a healthcare professional or emergency service gives you disposal instructions, follow those instructions. Otherwise, keep the item secured while you complete the report and obtain professional advice.
Independent reader supportYour contribution helps us test, update, and keep practical guides available for everyone.Reporting outside the United States
FDA channels apply to U.S. reporting. In another country, contact a pharmacist or doctor and report the suspicion to the country’s National Medicines Regulatory Authority. The authority’s name, online form, telephone number, and evidence requirements vary by jurisdiction, so use the current instructions for the country where the medicine was supplied or used.
“You should also report your suspicion to the National Medicines Regulatory Authority.” — World Health Organization, advice to patients and consumers on substandard and falsified medical products
WHO’s global surveillance system receives information through trained national-authority focal points and international procurement agencies. It is not described as the ordinary direct consumer reporting portal. A consumer should normally start with a healthcare professional and the national regulator rather than attempting to submit directly to the global system.
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When crossing borders, record the country of purchase, the country where the product was used, and any importer or distributor named on the label. Those details can help the appropriate authority determine which jurisdiction should handle the report.
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Common reporting questions and decisions
Can I report a product problem if nobody had a reaction?
Yes. A suspected counterfeit or contaminated medicine is a product-quality concern even when no adverse reaction occurred. Include the product identifiers and explain the reason for suspicion.
Do I need laboratory proof?
No. Report the reasonable suspicion and the observations behind it. FDA’s adverse-event instructions do not require certainty about a cause-and-effect relationship, and a consumer is not expected to establish authenticity or contamination independently.
What if I have only the medicine and no receipt?
Submit the identifiers and observations you have. State that the purchase source or date is unknown. A missing receipt should not stop a report when the product itself can be described.
Should a healthcare professional report as well?
Tell the clinician or pharmacist about the suspected product. Consumers and professionals can report product problems and adverse events to MedWatch; a professional may also have clinically relevant treatment and examination information.
Can I report a seller without naming the medicine?
Give as much product information as possible, because seller reports are easier to evaluate when linked to a specific listing, package, order, or shipment. If the product identity is unknown, report the seller details and explain what is missing rather than inventing an identification.
A practical report checklist
- Get medical help promptly if the medicine was used or anyone has symptoms.
- Secure the remaining product and packaging if safe and practical.
- Copy the name, strength, manufacturer or labeler, NDC, lot number, and expiration date when available.
- Write a short timeline of purchase, receipt, use, discovery, and symptoms.
- Describe observable differences and suspected contamination without claiming unproven certainty.
- Submit a MedWatch product-problem report in the United States.
- Select the adverse-event category too when a product problem may have caused or contributed to symptoms.
- Add an Office of Criminal Investigations report when the concern involves suspected criminal counterfeit activity.
- Add the FDA unlawful-sales or unsafe-online-pharmacy report when a website, account, or seller is part of the problem.
- Outside the United States, contact a healthcare professional and the National Medicines Regulatory Authority for the relevant country.
Why reporting matters even when the evidence is incomplete
Regulators compare product identifiers, descriptions, seller information, and reported reactions across separate submissions. A single consumer may not know whether a package is genuinely counterfeit, contaminated during manufacture, damaged in distribution, or mislabeled. Reporting the facts allows the responsible authority to evaluate patterns without requiring the consumer to reach the final conclusion.
The most useful report is timely, specific, and honest about uncertainty: identify the medicine, preserve the available evidence, explain what happened, and distinguish a direct observation from an inference. Medical care and safety remain the priority throughout.
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