FDA warns of counterfeit Alli for weight loss

The FDA has warned consumers about a counterfeit and potentially harmful version of over-the-counter Alli (orlistat caps, from GlaxoSmithKline), indicated for use as an adjunct to reduced-calorie, low-fat diet for weight loss in overweight adults. Preliminary laboratory test conducted by GlaxoSmithKline revealed that the counterfeit version does not contain orlistat, but rather sibutramine. Sibutramine is a prescription FDA-approved active ingredient indicated as an adjunct to diet in the management of obesity that should not be used without physician oversight.

The counterfeit Alli product looks similar to the authentic product, with a few notable differences. Pictures of the counterfeit product can be found at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm197857.htm. The counterfeit Alli has:
  • Outer cardboard packaging missing a "Lot" code
  • Expiration date includes the month, day, and year (eg, 06162010); authentic Alli expiration date includes only the month and year (eg, 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 counterfeit Alli in their possession should stop using the product immediately and contact their healthcare provider if any adverse events occur that may be related to the use of the product.