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EarthLab Inc
FDA recall F-1346-2022 · Class II · reported 2022-06-29 · Terminated
- Product
- 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.
- Reason
- The microbial test result is found to be out of specification due to high yeast and mold counts.
- Quantity
- 1,213 units
- Distribution
- nationwide
- Firm location
- OR, United States
- Initiated
- Voluntary: Firm initiated
- First notice
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Recall started
- 2022-05-11
- Terminated
- 2023-05-22
- Code info
- 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).
Source: U.S. Food and Drug Administration, openFDA Food Enforcement database (openFDA Food Enforcement, imported 2026-09). The FDA does not validate openFDA data for completeness or accuracy. This is a record of an enforcement action, not safety advice.