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Class II: temporary or reversible health riskTerminated

EarthLab Wise Woman Herbals Standardized Kava Recall

Wise Woman Herbals Standardized Kava Glycerite, product is liquid and contains 15 mg Ka…

EarthLab Inc · Creswell, OR

Risk level
Class II
Reported by FDA
Jun 29, 2022
Recall ID
F-1347-2022
Check your lot numberHow we source this data

Summary

EarthLab recalled Wise Woman Herbals Standardized Kava starting May 11, 2022. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report F-1347-2022 on Jun 29, 2022. Reason: The microbial test result is found to be out of specification due to high yeast and mold counts. Status: Terminated.

Why it was recalled

The microbial test result is found to be out of specification due to high yeast and mold counts.

Product description

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 bottle, Black serrated polypropylene dropper assembly with rubber bulb (2oz only) or Black serrated phenolic lid with polypropylene cone insert (4oz and larger), Clear neck band, Wise Woman Herbals label. Each size has the following UPCs: 2 oz UPC 7 48840 14275 6 4 oz UPC 7 48840 14276 3 8 oz UPC 7 48840 14277 0 16 oz UPC 7 48840 14278 7 32 oz UPC 7 48840 14279 4

Lot numbers, UPCs & expiration codes

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).

Where it was sold

nationwide

What to do if you have this product

  • Compare the brand, size, and lot/UPC codes on your package with the codes above.
  • If it matches, don't eat it. Return it to the store for a refund or throw it away.
  • Wash surfaces and containers that touched the product.
  • If you feel sick after eating it, contact your doctor. In an emergency call 911.

Recall details

Recall number
F-1347-2022
Classification
Class II
Status
Terminated
Recall initiated
May 11, 2022
FDA report date
Jun 29, 2022
Quantity
2 fl oz = 704 units; 4 fl oz = 262 units; 8 fl oz = 65 units; 16 fl oz = 30 units; 32 fl oz = 1 unit
Recall type
Voluntary: Firm initiated
Recalling firm
EarthLab Inc

Original FDA data

Every field from FDA enforcement report F-1347-2022, exactly as published.

Show all FDA fields
City
Creswell
State
OR
Status
Terminated
Country
United States
Event ID
90203
Address
185 N Mill St
Code information
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).
Postal code
97426-9888
Report date
Jun 29, 2022
Product type
Food
Recall number
F-1347-2022
Classification
Class II
Recalling firm
EarthLab Inc
Product quantity
2 fl oz = 704 units; 4 fl oz = 262 units; 8 fl oz = 65 units; 16 fl oz = 30 units; 32 fl oz = 1 unit
Termination date
May 22, 2023
Reason for recall
The microbial test result is found to be out of specification due to high yeast and mold counts.
Voluntary / mandated
Voluntary: Firm initiated
Product description
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 bottle, Black serrated polypropylene dropper assembly with rubber bulb (2oz only) or Black serrated phenolic lid with polypropylene cone insert (4oz and larger), Clear neck band, Wise Woman Herbals label. Each size has the following UPCs: 2 oz UPC 7 48840 14275 6 4 oz UPC 7 48840 14276 3 8 oz UPC 7 48840 14277 0 16 oz UPC 7 48840 14278 7 32 oz UPC 7 48840 14279 4
Distribution pattern
nationwide
Recall initiation date
May 11, 2022
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Center classification date
Jun 22, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report F-1347-2022, published Jun 29, 2022. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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