Agency classClass IIOur severity:High FDA (Food)·F-1347-2022·Announced 2022-06-29

Kava Glycerite Recalled Due to High Yeast and Mold Contamination

EarthLab Inc is recalling Wise Woman Herbals Standardized Kava Glycerite due to high yeast and mold counts detected during microbial testing. The affected product was distributed nationwide.

The agency’s classification

FDA (Food): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving microbial contamination (high yeast and mold counts) in a consumable dietary product. While no illnesses or injuries have been reported, the contamination constitutes a risk-of-harm product that meets the High severity criterion.

Plain-English summary

EarthLab Inc is recalling Wise Woman Herbals Standardized Kava Glycerite, a liquid dietary supplement containing kavalactones from Piper methysticum (kava), at strengths of 15 mg or 9 mg per dose depending on the lot. The product is available in multiple sizes (2 oz, 4 oz, 8 oz, 16 oz, and 32 oz bottles).

Microbial testing has revealed that affected batches contain high yeast and mold counts that exceed acceptable limits. This contamination poses a potential health risk if the product is consumed.

The recall affects five specific lots distributed nationwide: Lot 17816 (Best Used By 9/10/23), Lot 17391 (Best Used By 10/2/22), Lot 16988 (Best Used By 10/24/21), Lot 16872 (Best Used By 8/7/21), and Lot 16742 (Best Used By 4/25/21). Affected products can be identified by the lot codes 2PIGL, 4PIGL, 8PIGL, 16PIGL, and 32PIGL (where the first digit indicates package size).

Consumers who have purchased this product should stop using it immediately and discard it or return it to the place of purchase.

The recalled product

Product: Wise Woman Herbals Standardized Kava Glycerite, product is liquid and contains 15 mg Kavalactones (from Piper methysticum) and 9 mg Kavalactones (from Piper methysticum) depending on lot. Dosage: 60 drops 1-2 times a day. Product is packaged in Amber Glass Boston Round…
Manufacturer: EarthLab Inc
Category: Food — Dietary Supplement / Herbal
Hazard: yeast
mold

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 (16)

2PIGL
4PIGL
8PIGL
16PIGL
32PIGL. (1st digit indicates package size
PI indicates Piper
Latin name of Kava
GL indicates Glycerite). Lots: 17816
17391
16988
16872
16742. Best Used By for each lot: 9/10/23 (for 17816)
10/2/22 (for 17391)
10/24/21 (for 16988)
8/7/21 (for 16872)
4/25/21 (for 16742).

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by EarthLab Inc under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · EarthLab Inc

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