How to Report a Problem to the FDA

Call 911 or go to an emergency room if you are experiencing a serious reaction. For poisoning, call 1-800-222-1222 (Poison Control, 24/7, free, confidential).

FDA reports are for tracking patterns and triggering recalls — they are not a substitute for medical care. File the report after you and your family are stable.

The FDA uses different intake systems for different products:

Drugs, biologics, vaccines, dietary supplements — MedWatch

Report adverse events (side effects, allergic reactions, overdoses, drug interactions, lack of expected effect, quality problems) through MedWatch.

• Online: FDA Safety Reporting Portal
• Phone: 1-800-FDA-1088 (1-800-332-1088)
• Fax: 1-800-FDA-0178 (paper form: FDA Form 3500)

Medical devices — MedWatch (consumer) or MAUDE (industry)

Patients and caregivers use MedWatch (above) for malfunctions, injuries, or deaths involving medical devices like pacemakers, insulin pumps, CPAP machines, hip implants, and surgical instruments.

• Online: FDA Safety Reporting Portal
• For the at-home tester or healthcare professional submission flow, the same portal handles both.

Packaged food, dietary supplements, cosmetics — Consumer Complaint Coordinator

For foodborne illness, contamination, mislabeling, foreign objects, or cosmetic reactions:

• Online: FDA Consumer Complaint Coordinator directory (state-by-state phone numbers)
• Foodborne illness specifically: How to report a food problem
• Cosmetics: report through MedWatch if the issue caused a medical reaction.

Tobacco products

Use the Safety Reporting Portal for problems with cigarettes, e-cigarettes, vaping devices, and other tobacco products regulated by the FDA.

For any FDA report, the more specific the better:

• Product name (brand, generic, strength, dosage form)
• Lot number, NDC number, UPC, or device serial number (usually on the packaging or device label)
• Manufacturer and where you bought it
• Date the problem occurred and how long after first use
• Description of the reaction or defect — symptoms, severity, treatment, outcome
• Other medications or products being used at the same time
• Patient age, sex, and relevant medical history (kept confidential)
• Photos of the product, packaging, label, and any visible defect

You do not need to be sure the product caused the problem to file a report. The FDA uses incomplete reports as part of pattern analysis.

Do not stop, change, or discard a prescription medication on your own, even if you suspect it is causing a problem. Call your doctor or pharmacist first — stopping a medication abruptly can cause its own serious problems.

Your doctor can also help file the MedWatch report and may have important clinical context to include. Pharmacists and hospitals routinely submit MedWatch reports on behalf of patients.

• Reports are entered into FDA databases like FAERS (drugs), MAUDE (devices), or CFSAN Adverse Event Reporting (food/supplements/cosmetics).
• FDA staff pattern-match across thousands of reports to spot emerging safety signals.
• If a pattern is found, the FDA can require a label change, safety communication, or recall.
• Most reports become part of the public FAERS or MAUDE databases (with personal information redacted).
• You typically do not receive a direct response — the report feeds the FDA's surveillance system.