Partnership for Safe Medicines
SafeMeds Alert
UPDATED: FDA Alert Regarding Counterfeit Alli
January 26, 2010
Updated FDA Alert Regarding Counterfeit Alli

The U.S. FDA released an updated public health alert regarding counterfeit Alli being sold over the internet.

According to the FDA, here's what you need to know:

  • Alli is an FDA-approved, over-the-counter weight loss drug.
  • FDA lab tests have confirmed that counterfeit versions of the drug do not contain the FDA-approved active ingredient; rather, they are made with varying amounts of the stimulant sibutramine.
  • Sibutramine can be particularly harmful to those who have a history of cardiovascular disease and can lead to elevated blood pressure, stroke or heart attack.
  • The counterfeit drugs have been identified as Alli 60mg capsules (120 count refill pack)

If you take Alli, it's important that you check it for:

  • Missing lot numbers on the outer cardboard packaging;
  • An expiration date that includes a month, day and year-expiration dates on legitimate packages include the month and year only;
  • A wordless inner safety seal-the real product contains the words "SEALED FOR YOUR PROTECTION" on its inner seal;
  • Large capsules containing white powder instead of  small white pellets; and
  • A taller bottle with a wider, coarser cap than real Alli packaging

See photos of counterfeit Alli next to the real thing.

If you think you're in possession of counterfeit Alli, please inform the FDA's Office of Criminal Investigations (OCI) at 800-551-3989 or via their Web site.  


FDA's Office of Criminal Investigations (OCI)
(800) 551-3989
FDA's MedWatch Program
(800) FDA-1088
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About the SafeMeds Alert System
As part of the FDA's Alert Network, the SafeMeds Alert System is a free service that sends official alerts from the FDA and other government agencies around the world to anyone-private citizens, public groups, corporations, associations-when specific counterfeit drug incidents occur.

The SafeMeds Alert System is a service of the Partnership for Safe Medicines-a group of organizations and individuals that have policies, procedures, or programs to protect consumers from counterfeit or contraband medicines.  For more information, please visit