Shaman Botanicals recalls chewable tablets over undeclared concentration of active ingredient

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Martin A Makary M.D., M.P.H. | U.S. Food and Drug Administration

Shaman Botanicals recalls chewable tablets over undeclared concentration of active ingredient

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Shaman Botanicals, LLC has announced a voluntary nationwide recall of one lot of its Alkaloids Chewable Tablets—White Vein after tests found the product contained higher levels of 7-Hydroxymitragynine (7-OH) than declared. The company stated, "Recent testing showed that the Alkaloids Chewable Tablets—White Vein product contains 7-Hydroxymitragynine (7-OH) in an amount more than the declared value of 7.5 mg/tablet."

According to Shaman Botanicals, consuming these tablets could result in users ingesting more of the compound than intended, potentially leading to adverse health effects. The company reported it has not received any complaints or reports of adverse events linked to this specific lot.

The recalled products were distributed across the United States through wholesalers, retailers, and online sales. They were sold in packaging containing two, twenty, or thirty tablets with UPC codes 810057763724, 810057763830, and 810057763779 respectively. All packages affected are marked with Lot B# AAW.501.3.

Distributors and customers have been notified by email about the recall and instructions for returning the affected products for a refund or replacement have been provided. The company advised those in possession of the recalled tablets to stop using them immediately and return them.

Customers seeking refunds or replacements can register their returns at https://recall.cbdamericanshaman.com/. For questions regarding the recall, consumers can contact Vince Sanders at Shaman Botanicals’ Quality Department by phone at 855-427-7386 or by email at Quality@CBDAmericanShaman.com.

Consumers who believe they may have experienced problems related to this supplement are encouraged to contact their healthcare provider. Adverse reactions can also be reported directly to the FDA’s MedWatch program online or via mail or fax as detailed on www.fda.gov/medwatch/report.htm.

The U.S. Food and Drug Administration is aware of this recall.

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