The U.S. Food and Drug Administration (FDA) issued a recall on all Triangle Pharmanaturals LLC’s Kratom products, for being tested positive for salmonella.
The rare mandatory recall was announced following test results on several kratom products belonging to Triangle Pharmanaturals LLC showing positive for salmonella. The FDA thus has recalled all kratom products manufactured, processed, packed or held by the company.
The FDA has advised consumers to throw away any products associated with the recall, including Raw Form Organics Maeng Da Kratom Emerald Green, Ivory White, and Ruby Red.
“This action is based on the imminent health risk posed by the contamination of this product with salmonella, and the refusal of this company to voluntarily act to protect its customers and issue a recall, despite our repeated requests and actions,” said Dr. Scott Gottlieb, FDA Commissioner. This is the first time the agency recalled a company’s products due to lack of cooperation.
Kratom is a native plant of Malaysia. In the U.S., kratom is sold as a dietary supplement in the form of pills, powders, capsules, and tea to help treat pain and reduce opioid withdrawal cravings.
FDA and the U.S. Centers for Disease Control and Prevention, jointly investigated that the supplement is linked to an outbreak of at least 87 cases of salmonella across 35 states, starting in October 2017.
Salmonella is associated with symptoms such as diarrhea, fever, and abdominal cramping 12 to 72 hours after a person has been infected. In most cases, it lasts for four to seven days, requiring no treatment, while hospitalization may be required in case of severe diarrhea. The outbreak began February 24, recorded hospitalizations of twenty-seven people, aged 6-67 years.
From among 55 patients interviewed by Federal health investigators, 40 reported consumption of kratom pills, tea or powder before the start of their symptoms.