[7/5/2018] The Food and Drug Administration (FDA) is advising consumers not to use Blissful Remedies kratom products sold by World Organix LLC, Las Vegas, Nevada. FDA laboratory analysis found that the products are contaminated with high counts of various bacteria that can cause infections, including Salmonella, Clostridium difficile, Klebsiella pneumoniae and Pseudomonas aeruginosa.
Blissful Remedies announced a recall on June 30, 2018. FDA is concerned this recall does not include all lot numbers of the affected products.
FDA has received reports of adverse events associated with kratom products. There are no proven medical uses for kratom and the public is strongly discouraged from consuming kratom. Kratom is an inherently addictive product that can cause harm.
FDA encourages health care professionals and consumers to report adverse events or quality problems experienced with the use of any drug products to FDA’s MedWatch Adverse Event Reporting program:
- Complete and submit the report online at www.fda.gov/medwatch/report.htm; or
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.