Shaman Botanicals has recalled one lot of its Alkaloids Chewable Tablets-White Vein because testing shows it contains more 7-OH than is indicated on the label.
People who use the tablets could ingest a higher amount of the chemical than they intended, which could cause adverse health issues, according to the U.S. Food and Drug Administration.
According to the FDA, 7-OH “products are novel potent opioid products that have not been proven safe or effective for any use and should be avoided.”
7-Hydroxymitragynine occurs naturally in trace amounts in the plant kratom. The FDA’s warning applies to products with 7-OH as an added ingredient or at enhanced levels.
“7-OH is not approved by the FDA for any medical use and is not lawful as a dietary supplement or when added to conventional foods because it has not met the appropriate safety standard.”
Shaman Botanicals said it has not received any reports of illness related to the recalled product.
The Alkaloid Chewable Tablets-White Vein is packaged in a two-pack with the UPC 810057763724, in a 20-count bag with UPC 810057763830 and in a 30-count bottle with UPC 810057763779.
The recall includes all expiration dates of lot number B# AAW.501.3.
The product was distributed nationwide to wholesalers, retailers and consumers via online sales.
Customers can go to the recall website to register to return the product and receive a refund or replacement.
For more information, contact Vince Sanders in the quality department at 855-427-7386 between 10 a.m. and 6 p.m. ET, Monday through Friday, or send an email to quality@cbdamericanshaman.com.
Consumers should contact their health care provider if they have problems related to the supplement. Adverse reactions also can be reported to the FDA at fda.gov/medwatch/report.htm.