Safety Alerts & Recalls

What does this mean?

This excessive amount of sibutramine found in the counterfeit Alli is dangerous to people who have a history of heart disease, stroke, or other cardiovascular disease, and can lead to elevated blood pressure, stroke, or heart attack. Even healthy people who take this much sibutramine can experience anxiety, nausea, heart palpitations, a racing heart, insomnia, and small increases in blood pressure.

Check to make sure you are not taking counterfeit Alli. The counterfeit Alli has:

- a missing LOT code on the outer cardboard packaging

- an expiration date that includes a MONTH, DAY, and YEAR - the expiration date of the real Alli only contains a MONTH and a YEAR

- a plain foil for the inner safety seal without any words on it - the safety seal of the real Alli has the words "SEALED FOR YOUR PROTECTION" prominently printed on it

- large capsules with white powder, as opposed to small white pellets found in the real Alli

- a slightly taller plastic bottle with a wider cap and coarser ribbing on the cap than what is seen with the real Alli

Photograph examples of Alli and counterfeit Alli can be found here:

If you think you might have the counterfeit product: 1) stop taking the drug, 2) contact your healthcare professional if you are experiencing more than mild side effects, especially if you have a history of heart disease, stroke, or other cardiovascular disease, and 3) call the FDA's Office of Criminal Investigations (OCI) at 800-551-3989 or by visiting the OCI website: You may also contact Alli's maker, GlaxoSmithKline at 800-671-2554.

If you are not sure if you have counterfeit Alli, please follow up with your pharmacist or contact the FDA's OCI.

The FDA encourages people to report any unexpected side effects that may be related to the use of the counterfeit product to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.

Update on FDA Warning About Counterfeit Alli

Since last week's FDA alert about counterfeit Alli, the FDA has learned new information. FDA first warned consumers about the counterfeit product on January 18, 2010, based on preliminary laboratory tests that revealed the counterfeit version contained sibutramine and not orlistat. The counterfeit version of the weight-loss drug Alli 60 mg capsules (120 count refill pack) is being sold over the Internet, particularly at online auction sites such as eBay. Since that time of the first alert, FDA lab tests on the counterfeit product show that people may be taking three times the usual daily dose (and twice the recommended maximum dose) of sibutramine if they are following the dosing directions for the counterfeit Alli.

Alli is an FDA-approved, over-the-counter weight-loss drug that contains orlistat as its active ingredient. The counterfeit version of Alli does not contain orlistat; instead it is made with varying amounts of sibutramine, a stimulant drug. Although sibutramine is the active ingredient in another FDA-approved prescription weight-loss drug, it is only to be used in specific doses and under the supervision of a physician.

For more information, please visit: more information here and

more information here

To read the iGuard Safety Alert from January 18, 2010, please visit: more information here

Source: FDA
Publication Date: 2010-01-26
Last Updated: 2010-01-26

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