Food recall

EarthLab Inc recall: Wise Woman Herbals Kava Capsules

EarthLab Inc, of Creswell, OR, recalled Wise Woman Herbals Kava Capsules and 2 other products. The FDA's reason: “The microbial test result is found to be out of specification due to high yeast and mold counts.” The FDA classified it Class II: it could cause temporary or minor harm. The company began the recall voluntarily on May 11, 2022, and the FDA first listed it in its Enforcement Report of June 29, 2022. The FDA has closed the recall: it found the company did all it reasonably could to remove or correct the product.

How serious

Class II

It could cause temporary or minor harm

Why

Other germs or toxins (botulism, hepatitis A, mold...)

Status

Terminated

Closed May 22, 2023

The recall

Company
EarthLab Inc (Creswell, OR)
Reason, in FDA's words
“The microbial test result is found to be out of specification due to high yeast and mold counts.”
Where it was sold
nationwide
Recall began
, by the company
FDA classified it
First in an FDA Enforcement Report
FDA event number
90203

The 3 products recalled

As the FDA describes them, with the codes that tell whether a package is part of the recall.

  • F-1346-2022 Class II

    Wise Woman Herbals Kava Capsules, 450 mg Kava (Piper met. Root), Dosage: 1 capsule up to 3 times per day day at 450mg Kava root. 90 counts per bottle. UPC 7 48840 14284 8. Kava Capsules older lots are packaged in 250cc Wide Mouth Amber Glass Packer, Black 45/400 PP ribbed skirt screw-top lid, clear neck band, Wise Woman Herbals Large botanical label. Kava Capsules newer lots are packaged in White polypropylene packer style bottle, White serrated flat-topped lid with foam liner, clear neckband, Wise Woman Herbals label.

    Codes: 90KACA (90 indicates package size; KA indicates Kava; CA indicates capsule). Lots: 16754, 17157, and 17764-1. Best Used By for each lot: 10/22/21 (for 16754); 10/22/22 (for 17157); 1/26/24 (for 17764-1).

    Quantity: 1,213 units

  • F-1347-2022 Class II

    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

    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).

    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

  • F-1348-2022 Class II

    Wise Woman Herbals Sleepytime Glycerite. Product is liquid and strength is 20% presence in formula. Dosage: 60 drops 1-4 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 14269 5 4 oz UPC 7 48840 14270 1 8 oz UPC 7 48840 14271 8 16 oz UPC 7 48840 14272 5 32 oz UPC 7 48840 14273 2

    Codes: 2SLGL, 4SLGL, 8SLGL, 16SLGL, 32SLGL. (1st digit indicates package size; SL indicates Sleepytime; GL indicates Glycerite). Lots: 17950, 17724, 17648, 17338, 17019, 16963, 16905. Best if Use for each lot: 10/19/23 (for lot 17950); 3/24/23 (for lot 17724); 3/2/23 (for lot 17648); 9/29/22 (for lot 17338); 11/25/21 (for lot 17019); 9/20/21 (for lot 16963); 8/14/21 (for lot 16905).

    Quantity: 1 fl oz = 1,010 units; 2 fl oz = 1,219 units; 4 fl oz = 282 units; 8 fl oz = 46 units; 16 fl oz = 16 units; 32 fl oz = 4 units

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Source and notes

U.S. Food and Drug Administration, Enforcement Reports (openFDA food recall data) (Public domain (U.S. government work); source U.S. Food and Drug Administration, openFDA), data as of June 29, 2022.

Each week the FDA lists the recalls it has classified in its Enforcement Report, often weeks after the company announced the recall, so a month with five weekly reports tends to count more. Each recall counts once, however many products it covers, in the month FDA first listed it. Class I means the food could cause serious harm or death, Class II temporary or minor harm, and Class III is unlikely to harm anyone. Meat, poultry and most egg products are recalled by the U.S. Department of Agriculture, not the FDA, and aren't included. For what to do with a recalled product, see the FDA's recalls page.