Alli Recall Issued for Weight Loss Pills Following Tampering Reports

A day after GlaxoSmith Kline warned that some Alli bottles were tampered with, the drug maker has recalled all lots of the over-the-counter weight loss drug, pulling its entire U.S. supply from pharmacy and drug store shelves.  

The Alli recall was announced on March 27, as the company and the FDA conduct an investigation into the alleged tampering.

Reports from at least seven different states have been received from consumers who purchased the weight loss drug and discovered a variety of other pills inside the bottles that were not the Alli medication. The bottles showed evidence of tampering.

GlaxoSmithKline has indicated that in some cases, the bottles inside the outer carton had no labels and in other cases it was clear that the bottles did not have the authentic tamper-evident seals.

“Safety is our first priority and we are asking retailers and pharmacies to remove all Alli from their shelves immediately,” GSK’s President of Consumer Healthcare North America, Colin Mackenzie, said in the company’s press release.

The company has placed a consumer alert on the Alli website at www.myalli.com. It has also issued photographs of authentic pills, bottles, cartons and seals to help consumers better detect tampering. Cases of tampering have been reported in Alabama, Florida, Louisiana, Mississippi, New York, North Carolina and Texas.

The authentic Alli capsule is turquoise blue with a dark blue band. It comes in a labeled bottle that has an inner foil seal imprinted with the words “Sealed for your Protection.” The lot numbers and expiration dates on the outer carton and bottle should match.

Alli (orlistat 60mg) is an over-the-counter obesity drug approved by the FDA in 2007, which prevents the absorption of fats and is meant to be used alongside a reduced caloric diet. The active ingredient orlistat has been linked to concerns in recent years about a potential risk of liver damage, resulting in investigations by agencies in the United States and Europe.

In 2009, the FDA issued a warning about the potential risk of liver damage from Alli, and the stronger prescription version, Xenical, after an analysis of 32 case reports conducted between 1999 and 2008. The FDA warned consumers of rare reports of serious liver injury after use of the drugs. At least 13 cases of severe liver injury with Alli and Xenical were found during the investigation, including two incidents where patients died and three other incidents requiring patients to receive a liver transplant.

The types of drugs found in the compromised bottles of alli were not named, but there are always serious concerns about taking unknown drugs. Consumers could experience unexpected drug interactions, may be unable to tolerate certain drugs or may experience other, potentially fatal, side effects.

GlaxoSmithKline warns that consumers should not use Alli if it does not match that description or if they have any concerns about its authenticity. The company also advises anyone who believes they took another drug when they thought they were taking Alli to contact their healthcare provider.

Anyone who believes they have purchased inauthentic Alli pills are urged to call GlaxoSmithKline’s Consumer Relations line at (800) 671-2554. They should retain all packaging information, including seals, pamphlets, boxes and bottles.