ISSUE: Botanical Laboratories Inc. and FDA notified consumers and healthcare professionals of a recall of Wellesse Digestive 3 in 1 Health liquid dietary supplement. A supplier of one of the ingredients indicated the ingredient has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience: fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
BACKGROUND: Product lots affected by this recall include: 16 oz. size with "LOT 34441C (followed by a four digit time code) A EXP 03/2014" jet coded on the bottom of the bottle. 33.8 oz. size has "LOT 34552C (followed by a four digit time code) A EXP 03/2014" jet coded on the bottom of the bottle.
Both 33.8 oz. and 16 oz "Digestive 3 in 1 Health" were distributed nationwide through retail stores, and online retailers. The product was distributed after 05/01/2012.
RECOMMENDATION: Consumers who have purchased Wellesse "Digestive 3 in 1 Health" with one of the above referenced lot numbers are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company at 1-800-232-4005.
Consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[06/04/2012 - Press Release - Botanical Laboratories]
[06/07/2012 - Product Photos - Wellesse Digestive 3 in 1 Health - FDA]