White Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
Shaman Botanicals, LLC is recalling White Vein Advanced Alkaloids Chewable Tablets because testing found the active ingredient 7-hydroxymitragynine is present in a quantity greater than the labeled specification.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class I recall. Per the rubric, FDA Class I recalls with no other disqualifying factors default to a score of at least 4 (Severe). This reflects the agency's determination that the hazard—excess active ingredient in a dietary supplement—has a reasonable probability of causing serious adverse health consequences.
Plain-English summary
Shaman Botanicals, LLC is recalling White Vein Advanced Alkaloids Chewable Tablets in lemon flavor. The recall affects product with lot number B#AAW.501.3 and UPC 810057763779 (sometimes preceded by 00), with all expiration dates. Approximately 97,063 units have been distributed.
A sample of the product revealed the active ingredient is in a quantity greater than the labeled specification. The product was distributed to 14 wholesalers, 108 distributors, 46 company-owned stores, and 2,202 online customers.
Consumers who have purchased this product should stop using it and contact Shaman Botanicals, LLC or their place of purchase for further instructions.
The recalled product
- Product
- Product label reads in part as "WHITE VEIN ADVANCED ALKALOIDS CHEWABLE TABLETS 225mg 7-Hydroxymitragynine per container (7.5mg 7-OH per serving) LEMON DIETARY SUPPLEMENT Net Wt. 0.25 oz 30 TABLETS Supplement Facts 7-hydroxymitragynine 7.5 mg MANUFACTURED BY: Konig Products, LLC 3
- Manufacturer
- Shaman Botanicals, LLC
- Category
- Food — Dietary Supplement
- Hazard
- mis-labeling
- excess-active-ingredient
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- B#AAW.501.3
- UPC 810057763779 (sometimes proceeded by 00)
- all expiration dates
Distribution
Distribution scope not specified by the agency.
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