Counterfeit (fake or falsified) medicines may be harmful to your health because while being passed off as authentic, may contain the wrong ingredients, contain too much, too little or no active ingredient at all or contain other harmful ingredients.
The U.S. drug supply is among the safest in the world. The U.S. has federal and state laws that create a “closed” drug distribution system to help ensure the U.S. drug supply is safe. FDA remains vigilant in protecting the U.S. drug supply from counterfeits drugs.
However, there has been an increase in overdose deaths that are related to fentanyl-laced counterfeit drugs. Visit Overdose Prevention Framework and CDC’s Drug Overdose Deaths with Evidence of Counterfeit Pill Use for more information.
FDA takes reports of suspect counterfeits seriously and works closely with other federal agencies and the private sector to help protect the nation's drug supply.
Possible Signs of Counterfeit Drugs
Health care providers and consumers need to be aware of how they could be exposed to counterfeit medicines. Watch out for possible signs of a counterfeit drug:
- Does the drug or packaging look different than what you normally receive?
- Have you experienced a new or unusual side effect after using the drug?
- Did you buy the drug from an online pharmacy?
Consumers, health care providers and supply chain stakeholders should only buy from state-licensed pharmacies to ensure you are getting safe, effective and high-quality drugs that have been approved by FDA.
Visit BeSafeRx for more information about the potential dangers of buying medicine from online pharmacies.
Company Reports of Counterfeit Drugs
Companies report counterfeit drugs to FDA, and the agency provides this information to consumers:
- Novo Nordisk Warns Consumers about Counterfeit Ozempic (semaglutide) injection 1 mg in the U.S. (December 21, 2023)
- Novo Nordisk warns of counterfeit Ozempic (semaglutide injection) pen found in U.S. (June 16, 2023)
- Bausch + Lomb: Counterfeit Versions of Muro 128 (Sodium Chloride Hypertonicity Ophthalmic Ointment, 5%) and Muro 128 (Sodium Chloride Hypertonicity Ophthalmic Solution, 5%) Found in the U.S. (April 25, 2023)
- Janssen alerts counterfeit Symtuza is being distributed in the U.S. (December 24, 2020)
- Report sales of medicine by unsafe online pharmacies to the FDA
- Report adverse effects caused by any medicine to FDA’s MedWatch program
- Report suspected criminal counterfeit activity to FDA’s Office of Criminal Investigations
Many counterfeit drugs are made abroad and arrive in the U.S. through the mail or are smuggled into the country. FDA works with U.S. Customs and Border Protection and focuses on areas that present the most substantial threat to our drug supply.
Drug safety and quality do not begin or end at the U.S. border. The U.S. government works with foreign regulatory counterparts, when possible, to disrupt or close illegal operations involving the production and distribution of counterfeit drugs.
Visit Centers for Disease Control and Prevention’s counterfeit medicines for helpful safety tips when traveling abroad.
FDA Actions to Protect Against Counterfeit Drugs
- Works with industry and stakeholders to create a tighter, closed prescription drug distribution system to prevent harmful drugs from entering the supply chain, detect harmful drugs if they do enter the supply chain, and enable rapid response when such drugs are found.
- Electronically screens all FDA-regulated drugs imported into the U.S. to ensure imported drugs must meet FDA’s rigorous standards for quality, safety and effectiveness as drugs made in the U.S.
- FDA’s Office of Criminal Investigations conducts criminal investigations of illegal activities involving FDA-regulated products, arresting those responsible and bringing them before the Department of Justice for prosecution. This includes activities such as cybercrime and distributing counterfeit, unapproved and misbranded drugs.
- Drug Supply Chain Security Act (DSCSA) | FDA
- Department of Justice / Drug Enforcement Agency: Counterfeit Pill Fact Sheet
- Federal Trade Commission: Buying Prescription Drugs Online
- Centers for Disease Control and Prevention: counterfeit medicines
- Email firstname.lastname@example.org
Call 855-543-3784 or 301-796-3400
- Email the FDA Internet Pharmacy Task Force