FDA Drug Safety Communication Concerning Weight Loss Product Alli

From the FDA – The U.S. Food and Drug Administration is alerting consumers that GlaxoSmithKline (GSK) is withdrawing all lots of its weight loss product Alli from the U.S. market because some packages were tampered disclaimer icon with and may contain other kinds of pills. GSK is voluntarily initiating this national market withdrawal to protect consumers from purchasing tampered product.

FDA advises consumers not to purchase Alli at this time. Consumers who have purchased Alli should check the capsules inside the bottle to ensure that they are authentic. Alli is a turquoise blue capsule with a dark blue band imprinted with the text “60 Orlistat.” These tampering incidents include bottles without labels, broken safety seals, and bottles containing pills other than Alli.

Consumers who have concerns about the product they have purchased should not use it and call GSK at 800-671-2554.

FDA is working with GSK to investigate these tampering incidents. Consumers have reported purchasing tampered products at retail stores in Alabama, Florida, Louisiana, Mississippi, New York, North Carolina, and Texas.

Report Tampering

FDA has not received any reports of adverse events related to Alli. If consumers think they may have taken tampered Alli, they should contact their health care professional. FDA asks health care professionals and consumers to report any tampered product or adverse reactions to the FDA’s MedWatch program:

Complete and submit the report online at www.fda.gov/medwatch/report.htm

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