FDA Forces Unprecedented Mandatory Recall of Kratom Products

Triangle Pharmanaturals’ failure to comply with a voluntary recall led the FDA to hit them with a rare mandatory recall of all products.

Kratom Capsules / Image: Mary Esch
Kratom Capsules / Image: Mary Esch

An April 2nd CNN article discussed a rare mandatory recall issued by the FDA after several products from Triangle Pharmanaturals LLC tested positive for salmonella. This is the second instance in the past month where kratom products were found to contain salmonella, but the FDA said this is the first time it has had to use a mandatory recall for a food product after the company has refused to voluntarily recall their product.

The FDA has been warning against general use of kratom, which some use to treat pain in lieu of opioids, since last year. Back in November, FDA Commissioner Scott Gottlieb stated, “The FDA is aware of reports of 36 deaths associated with the use of kratom-containing products. There have been reports of kratom being laced with other opioids like hydrocodone. The use of kratom is associated with serious side effects like seizures, liver damage and withdrawal symptoms.”

FDA warning letters surge - is your team prepared?
New guide reveals expert strategies to prevent regulatory issues and respond effectively to FDA enforcement actions in pharmaceutical and medical device manufacturing.
Read More
FDA warning letters surge - is your team prepared?
Pharmaceutical Innovations Report
Discover the latest breakthrough packaging technologies shaping the pharmaceutical sector. This report dives into cutting-edge innovations, from smart containers that enhance patient safety to eco-friendly materials poised to transform the industry’s sustainability practices. All from PACK EXPO. Learn how forward-thinking strategies are driving efficiency and redefining what’s possible in pharma packaging.
Learn More
Pharmaceutical Innovations Report