FDA Warns Consumers About Fake Alli

Counterfeit Version of OTC Alli Sold Online

alli capsules
The fake Alli capsules contain a powder-like substance while the genuine Alli capsules' contents have a pellet-like appearance. Image: FDA.gov

*New information about alli weight loss pills and the diet pill recall is available here

The Food and Drug Administration has issued a warning to consumers about fake Alli pills. A counterfeit version of Alli that is potentially harmful has been sold online.

Alli is an FDA-approved over-the-counter weight-loss pill. Alli capsules prevent the body from absorbing some of the fat in users' diets. Its active ingredient, orlistat, attaches to enzymes in the digestive system and prevents absorption of about 25% of dietary fat consumed.

(The undigested fat passes through the digestive system and out of the body, and is therefore not absorbed.)

Alli is comprised of a half-dose of the prescription-only weight-loss medication known as Xenical. The active ingredient in both Xenical and Alli is orlistat. Alli became available at retailers in the U.S. in June 2007 in 60-mg capsules. It is sold as a 60-count starter pack, a 90-count starter pack and a 120-count refill.

The counterfeit version of Alli was purchased in the form of the 120-count refill by consumers via the Internet. According to the FDA, there is no evidence that counterfeit Alli has been sold through retail stores.

The fake Alli was found to contain Sibutramine, a controlled substance that is not found in the real form of Alli, but in the prescription-only pill known as Meridia.

"Sibutramine is a drug that should not be used in certain patient populations or without physician oversight," said the FDA, in a statement.

The FDA stated that sibutramine may interact with other medications.

While the fake Alli may look similar to the real thing, the FDA has pointed out some noticeable differences that can help consumers identify counterfeit product. The fake Alli has the following characteristics:

  • Outer cardboard packaging missing a "Lot" code;
  • Expiration date that includes the month, day, and year (e.g., 06162010); authentic Alli expiration date includes only the month and year (e.g.,: 05/12);
  • Packaging in a plastic bottle that has a slightly taller and wider cap with coarser ribbing than the genuine product;
  • Plain foil inner safety seal under the plastic cap without any printed words; the authentic product seal is printed with "SEALED for YOUR PROTECTION";
  • Contains larger capsules with a white powder, instead of small white pellets.

Consumers who believe they have received counterfeit Alli are asked to contact the FDA's Office of Criminal Investigations (OCI) by calling 800-551-3989 or by visiting the OCI Web site.


Food and Drug Administration. FDA News Release. FDA Warns Consumers About Counterfit Alli. 18 Jan 2010.

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