Shaman Botanicals Recalls Alkaloids Chewable Tablets Nationwide Over Undeclared Potency

Shaman Botanicals, LLC is initiating a voluntary recall of one lot of its Advanced Alkaloids Chewable Tablets—White Vein after tests revealed that the product contains levels of 7-hydroxymitragynine, a compound derived from kratom, that exceed the declared amounts, according to the company.

This nationwide recall affects Lot B# AAW.501.3 of the chewable tablets, irrespective of their expiration date. The company reported that recent testing indicated the product has 7-hydroxymitragynine (7-OH) levels surpassing the labeled amount of 7.5 milligrams per tablet.

In a notice released by the U.S. Food and Drug Administration on February 17, the company warned that consuming these tablets could lead to users taking a higher dose than intended, which may result in negative health effects.

Shaman Botanicals stated that it has not received any reports of adverse events associated with the recalled lot.

The affected product was distributed across the nation to wholesalers, retailers, and consumers, including through online sales. It was available in three packaging options: a two-count bag (UPC 810057763724), a 20-count bag (UPC 810057763830), and a 30-count bottle (UPC 810057763779). The lot number can be located on the packaging or the bottom of the bottle.

The company mentioned that it is reaching out to distributors and customers via email and is organizing the return of the affected products, providing refunds or replacements. Wholesalers, distributors, retailers, and consumers are advised to isolate the product, cease its use, and return it to the company.

Consumers who have encountered issues that may be linked to the use of this product are encouraged to consult a physician or healthcare provider. Adverse reactions can also be reported to the FDA’s MedWatch Adverse Event Reporting program.

The recall is being carried out with the FDA’s awareness, as stated by the company.