Safety Alerts & Recalls

What does this mean?

Since using this counterfeit Alli product could cause serious problems for certain patients, consumers who have bought Alli over the Internet should check their supply to see if it is counterfeit. The counterfeit Alli product looks similar to the authentic product, with a few notable differences. The counterfeit Alli has:

- 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.

Pictures of counterfeit Alli samples provided by GSK are available on the FDA webpage:

Consumers who believe they have received counterfeit Alli should stop using the product and contact the FDA's Office of Criminal Investigations (OCI) by calling 800-551-3989 or by visiting the OCI Web site ( If you are not sure if you have counterfeit Alli, please follow up with your pharmacist or contact the FDA's OCI.

If you have questions or if you think you are experiencing side effects from Alli or any other orlistat product, please follow up with your doctor. Healthcare professionals and consumers are encouraged to report adverse events that may be related to the use of these counterfeit products 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.

FDA Warns Consumers About Counterfeit Alli

The U.S. Food and Drug Administration (FDA) is warning consumers about a counterfeit and potentially harmful version of Alli 60 mg capsules (120 count refill kit).

Laboratory tests conducted by GlaxoSmithKline (GSK), the maker of the FDA approved Alli product, revealed that the counterfeit version did not contain orlistat, the active ingredient in its product. Instead, the counterfeit product contained the controlled substance sibutramine. Sibutramine is a drug that should not be used without physician oversight. Sibutramine can also interact in a harmful way with other medications that the consumer may be taking.

Consumers began reporting suspected counterfeit Alli to GSK in early December 2009. GSK has determined that the counterfeit product has been sold over the internet. At this time, there is no evidence that the counterfeit Alli product has been sold through other channels, such as retail stores.

Alli is an FDA approved over-the-counter weight-loss product that contains the active ingredient orlistat. Orlistat is also marketed under the name Xenical and is available by prescription.

For pictures of the counterfeit Alli and for more information, please visit: more information here and

more information here

Source: FDA
Publication Date: 2010-01-18
Last Updated: 2010-01-18

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