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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 someone became ill after taking it, report the suspected adverse event in the same submission and seek medical care promptly. Suspected criminal counterfeiting and an unlawful online seller require separate FDA reports because they concern different parts of the problem.
Outside the United States, contact a pharmacist or doctor and report the suspicion to your country’s National Medicines Regulatory Authority. The correct form and contact vary by country.
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Put the health concern first
A regulator’s report does not replace medical care. If the medicine was taken and the person has symptoms, a new health concern, or an unusual reaction, contact a healthcare professional promptly. A pharmacist, doctor, poison information service, or emergency service can advise on the immediate risk based on the medicine, dose, timing, and symptoms.
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Call emergency services for an emergency
Use emergency services when symptoms appear severe or rapidly worsening, or when the person may be in immediate danger. Do not wait to complete an FDA form before seeking urgent help. Take the medicine container or a photograph of its label if doing so is safe, but do not delay care to collect evidence.
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Do not experiment with the suspect medicine
- Do not taste, smell, dilute, crush, or otherwise test a suspect medicine yourself.
- Do not continue taking it merely to see whether the symptoms return.
- Do not assume that a replacement medicine is appropriate without advice from a healthcare professional.
Keep the remaining product and packaging aside only if that can be done safely and practically. A healthcare professional can tell you whether to stop, switch, or dispose of a medicine in light of your treatment needs.
Choose the reporting route that matches what happened
Several FDA routes may apply, but they are not interchangeable. Use the route for the specific concern, and make additional reports when more than one concern exists.
| What you suspect or observed | U.S. reporting route | What the route is for | What to do in parallel |
|---|---|---|---|
| The medicine may be counterfeit, contaminated, defective, or otherwise have a product-quality problem | FDA MedWatch, reported as a product problem | Gives FDA information about the medicine and the suspected quality issue | Contact a healthcare professional if anyone used it or has symptoms |
| A person had an illness, injury, side effect, or other suspected adverse event after use | FDA MedWatch adverse-event report | Records the patient’s experience and the suspected connection with the medical product | Select the product-problem category as well when the quality issue may have caused or contributed to the event |
| You suspect criminal counterfeit activity | FDA Office of Criminal Investigations (OCI) reporting route | Alerts FDA to suspected criminal conduct involving counterfeit products | File the MedWatch product-quality report as well when the medicine itself may be counterfeit or contaminated |
| A website, social-media account, or other seller may be unlawfully selling medicines | FDA route for unlawful sales or potentially unsafe online pharmacies | Reports the seller, website, account, or sales activity | Report the medicine to MedWatch if you received or used a suspect product |
| You are outside the United States | Your National Medicines Regulatory Authority | Routes the concern to the regulator responsible for medicines in your country | Speak with a pharmacist or doctor, especially after use or an adverse reaction |
How to report in the United States
1. Gather the information that is available
Before opening a report, write down what you know. Do not postpone a report because one field is missing; the critical details are the ones you can obtain from the label, package, receipt, order history, or your own notes.
| Information | Where to find it or what to describe |
|---|---|
| Product name | The exact name printed on the bottle, blister, tube, box, or package |
| Labeled strength | The amount per tablet, capsule, milliliter, dose, or other unit shown on the label |
| Manufacturer or labeler | The company identified on the product label as the manufacturer, distributor, or labeler |
| National Drug Code (NDC), when present | The NDC printed on the package or label; do not invent one if it is absent or unreadable |
| Lot or batch number, when available | The lot, batch, or control number on the package, bottle, blister, or seal |
| Purchase source | The pharmacy, clinic, website, social-media account, marketplace, or person from whom it was obtained |
| Relevant dates | When it was bought, first used, and when the difference, symptom, or suspected problem was noticed |
| What happened | Describe the suspected contamination or counterfeit concern, any unusual appearance, smell, packaging, effect, or side effect, and what happened after use |
Use factual observations rather than conclusions. For example, record that a tablet’s color differed from an earlier refill, that a seal was broken, or that a symptom began after a dose. An appearance difference, an unusual side effect, or an online purchase can be a warning sign, but none proves by itself that a medicine is counterfeit or contaminated.
2. File a MedWatch product-problem report
Use FDA MedWatch to report the suspected product-quality problem. FDA treats suspected counterfeit medicine and suspected contamination as product problems, including when no adverse reaction has occurred. Consumers and healthcare professionals can submit reports.
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Describe the product and the concern in the report’s narrative. Include the manufacturer or labeler, labeled strength, NDC when present, lot number when available, purchase source, dates, and any packaging or product differences. State whether the medicine was used and what happened afterward.
You do not have to prove that the product is counterfeit or contaminated before reporting it. A suspicion supported by the observations and identifying information you have is enough to submit a product-quality concern.
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If a person experienced an illness, injury, unusual symptom, or other suspected adverse event, include that event in the MedWatch report. FDA’s Form 3500 instructions say to select both the adverse-event and product-problem categories when a product problem may have caused or contributed to an adverse event.
Record the person’s symptoms, when they began, what happened after the medicine was taken, and whether medical care was sought. Describe the medicine and the suspected quality issue in the same submission so FDA can evaluate both the product and the patient experience.
Certainty about causation is not required. The FDA Instructions for Completing Form FDA 3500 state: 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.
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4. Report suspected criminal counterfeit activity to OCI
Use FDA’s Office of Criminal Investigations route when your concern involves suspected criminal counterfeit activity. This is a separate purpose from MedWatch: MedWatch records the product-quality concern, while OCI addresses suspected criminal conduct.
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5. Report the unlawful seller separately
If the medicine came from a website, social-media account, or other seller that may be operating unlawfully, use FDA’s reporting route for unlawful sales or potentially unsafe online pharmacies. Include the seller’s name, web address or account information, the date of purchase, and what was offered or shipped if those details are available.
This seller report does not replace the MedWatch report for the medicine itself. A seller can be unlawful even when a particular product is genuine, and a suspect product can require a product-quality report even when the seller’s legal status is unclear.
Preserve useful evidence safely
Keep the original container, outer box, blister pack, seals, inserts, and any remaining medicine when doing so is safe and practical. Save order confirmations, receipts, shipping labels, messages with the seller, and photographs of the package. These records can help identify the product and source.
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Do not handle a leaking, visibly hazardous, or otherwise dangerous product unnecessarily. Do not mail a sample or send it for a home test unless a healthcare professional or regulator gives you specific instructions. A home test result is not required to submit a report.
Independent reader supportYour contribution helps us test, update, and keep practical guides available for everyone.How to describe a suspected counterfeit or contaminated product
Counterfeit concerns
A counterfeit medicine is represented as an authentic product but may contain the wrong ingredient, too much or too little of an ingredient, no active ingredient, or an unsafe substitute. In a report, describe the facts that led to your suspicion: a mismatch in labeling, an unexpected tablet or liquid, an unfamiliar package, a source that appears deceptive, or a result that differs sharply from the expected medicine.
Contamination concerns
Contamination may involve an unwanted substance, a damaged seal, visible particles, an unexpected odor, discoloration, or another indication that the product may not be clean or safe. Record exactly what you observed and whether the product was opened, stored, or used. Do not state that contamination is confirmed unless a qualified authority has established it.
Warning signs are not proof
FDA identifies appearance differences, unusual side effects, and online purchase as possible warning signs. They justify careful attention and a report when the circumstances are concerning, but they do not establish the cause on their own. A genuine medicine can look different after a manufacturer change, and symptoms can have more than one cause. Let the regulator and healthcare professional evaluate the evidence.
If someone already took the medicine
Get clinical advice promptly
Tell the healthcare professional the exact product name, strength, dose, time taken, symptoms, other medicines or substances involved, and the suspected quality issue. Bring or photograph the label and packaging if possible. Follow the clinician’s instructions about further doses and treatment.
Report even when the cause is uncertain
Submit the MedWatch report when an adverse event may be related to the medicine, even if another cause is possible. FDA does not require certainty about a cause-and-effect relationship. If the medicine may also be counterfeit or contaminated, include the product-problem category and the identifying details in the same report.
Report a product problem even without symptoms
A suspected counterfeit or contaminated medicine can be reported as a product problem even when nobody became ill. Early reporting can give FDA information about a quality issue before an adverse event is known.
Reporting outside the United States
FDA channels apply to U.S. reporting. In another country, speak with a pharmacist or doctor and report the suspicion to the National Medicines Regulatory Authority responsible for medicines there. The regulator may use a product-quality form, an adverse-reaction system, a telephone line, or another national process.
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Repair common Windows errors and clear accumulated junk for a smoother, more stable PC - no reinstall needed.Free scan · no reinstallThe World Health Organization advises consumers to seek professional advice and says: You should also report your suspicion to the National Medicines Regulatory Authority.
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 portal for every country.
Because reporting contacts and forms differ by jurisdiction, confirm the current process with the national regulator or a local healthcare professional. Do not assume that a U.S. form, NDC field, or FDA route is used in your country.
Quick Recap
Common mistakes to avoid
- Waiting for proof: You can report a reasonable suspicion; you do not need laboratory confirmation or certainty.
- Reporting only the seller: A seller report does not substitute for reporting the medicine’s product-quality problem to MedWatch.
- Reporting only the product problem after an injury: Include the adverse event as well, and select both categories when the product problem may have contributed.
- Leaving out identifiers: Manufacturer or labeler, strength, NDC, lot number, purchase source, and dates help FDA evaluate the report. Include what is available.
- Treating appearance as a diagnosis: A different color, shape, smell, or package is a warning sign, not conclusive proof.
- Delaying care while filing: Medical attention comes before regulator paperwork when someone is ill.
- Using the wrong international channel: Outside the United States, use the national medicines regulator and local healthcare advice.
A practical reporting checklist
- If the medicine was taken, assess symptoms and contact a healthcare professional promptly; use emergency services for an emergency.
- Set aside the medicine and packaging safely, without tasting, testing, or continuing the suspect product.
- Record the product name, strength, manufacturer or labeler, NDC when present, lot number when available, source, dates, and observations.
- Submit the concern to FDA MedWatch as a product problem.
- If someone had an adverse event, include it in MedWatch and select both relevant categories when the product problem may have contributed.
- If criminal counterfeit activity is suspected, file the additional OCI report.
- If an online pharmacy, website, social account, or seller may be operating unlawfully, file the separate unlawful-sales report.
- If outside the United States, use the National Medicines Regulatory Authority and consult a pharmacist or doctor.
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