Wise Woman Herbals Standardized Kava Glycerite, product is liquid and contain...
FDA Recall #F-1347-2022 — Class II — May 11, 2022
Recall Summary
| Recall Number | F-1347-2022 |
| Date Initiated | May 11, 2022 |
| Classification | Class II |
| Status | Terminated |
| Type | Voluntary: Firm initiated |
| Product Type | Food |
Recalling Firm
| Firm | EarthLab Inc |
| Location | Creswell, OR |
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
Reason for Recall
The microbial test result is found to be out of specification due to high yeast and mold counts.
Classification
Class II — 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.
Distribution Pattern
nationwide
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
Product Codes / Lot Numbers
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).
What Should You Do?
Stop consuming this product immediately. Check your home for the recalled item and dispose of it safely. If you experienced a health issue after consuming this product, contact your doctor and report it to the FDA MedWatch.
Frequently Asked Questions
Stop consuming the product immediately and do not donate or give it to others. Check the recall notice above for specific disposal or return instructions. Many food recalls ask you to throw the product away and retain the packaging for a possible refund from the retailer. If you purchased it online, check your order history — some retailers send recall notifications directly to customers. You do not need a receipt to report an issue or seek a refund; the fact of purchase is typically sufficient.
In most cases, yes. Retailers are typically notified to accept returns of recalled products and issue refunds, regardless of whether you have a receipt. Check with the store where you purchased the item. Some manufacturers also offer direct refunds — contact the recalling firm using the information in the official recall notice. If you purchased the product online, contact the retailer's customer service with your order number. In either case, you generally do not need original packaging, though retaining the product label with the lot code or UPC can speed up the process.
Report foodborne illnesses and adverse food reactions to the FDA through the MedWatch Safety Reporting Portal at FDA.gov, or by calling 1-800-332-1088. You can also report issues directly to the FDA's Safety Reporting Portal at SafetyReporting.hhs.gov. If you believe there is an immediate public health risk, contact your local health department. Your report helps the FDA identify contamination patterns, initiate recalls faster, and protect other consumers from the same hazard. Include as much detail as possible: the product name, lot code, purchase date and location, and a description of your symptoms or findings.
The FDA assigns a status to each recall action throughout its lifecycle. "Ongoing" means the recall is active — the firm is still working to remove the product from commerce and notify consumers. "Completed" means the recall strategy has been implemented and the FDA has determined that the recalling firm has taken all appropriate steps to remove the product. "Terminated" means the FDA has reviewed the results and concluded the recall is complete. Even if a recall is marked as completed or terminated, you should still discard any recalled products you find at home — the recall status refers to the firm's compliance actions, not the safety of product still in consumers' possession.