Class I · Recall · initiated February 13, 2026 · Ongoing
Shaman Botanicals recalls 97,063 units of 7-OH chewable tablets that tested above label
A North Kansas City firm recalled 97,063 units of White Vein Advanced Alkaloids 7-hydroxymitragynine chewable tablets after a sample showed more active ingredient than the label states, across wholesalers, distributors, company stores and online buyers.
The record
- Firm
- Shaman Botanicals, LLC, North Kansas City, MO
- 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 30 N Gould Street, Su
- Reason, as filed
- “A sample of the product revealed the active ingredient is in a quantity greater than the labeled specification.”
- Classification
- Class I (Class I: reasonable probability of serious health consequences or death)
- Recall number
- H-1108-2026
- Initiated
- February 13, 2026
- Posted by FDA
- March 25, 2026
- Status
- Ongoing · Voluntary: Firm initiated
- Quantity
- 97,063 units
- Distribution
- Firm has provided the following information: 14 wholesalers, 108 Distributors, 46 Company-owned stores, 2202 online customers
Verify: search any recall number above in FDA's enforcement report database.
Why it happened, in plain English
The filed reason is that “a sample of the product revealed the active ingredient is in a quantity greater than the labeled specification.” For a tablet labeled at 7.5 mg 7-hydroxymitragynine per serving, that means the dose a consumer takes is not the dose on the label. The record does not say by how much, or which lot. The label names Konig Products, LLC as the manufacturer, so this is a brand recalling product made by another firm.
The record does not say how the overage happened. In general terms, potency overages in tablets come from three places: raw material stronger than assumed, a batch formula that did not adjust for the material’s assay, or a blend that was not uniform. Each is caught at a different point: incoming assay, batch record review, or finished-product testing. Whichever it was, the release check that should have held the lot did not.
Who else should care
Any supplement brand whose label carries a specific milligram claim for a single active compound, especially an extract or isolated alkaloid rather than a whole herb. The tighter the claim, the less room a raw material variation leaves. This applies double when a contract manufacturer makes the product and the brand only sees a certificate of analysis.
The distribution here is 14 wholesalers, 108 distributors, 46 company-owned stores and 2,202 online customers: four channels to notify and reconcile. Check: whether you hold a finished-product assay for each lot against the labeled amount, and a written spec with an upper limit, not only a minimum.
Written 2026-09-08. Analysis is editorial; the record above is FDA's.