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

United States

TerminatedClass II

Company
EarthLab Inc
Product
Wise Woman Herbals Sleepytime Glycerite. Product is liquid a…
Recall date
May 11, 2022
Terminated
May 22, 2023
Source
FDA

Reason for recall

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

  1. - Recall initiated
  2. - Reported by source
  3. - Recall terminated
Recalled products
Product description UPC Quantity Lot / code information
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 Not published in this source record 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 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).

Distribution

  • nationwide

Official source record

Agency
FDA
Dataset
FDA Food Enforcement (Recalls)
Recall number
F-1348-2022
Event ID
90203
Status
Terminated
Classification
Class II
Company
EarthLab Inc
Product description
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
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
Reason
The microbial test result is found to be out of specification due to high yeast and mold counts.
Recall initiation date
May 11, 2022
Report date
June 29, 2022
Classification date
Not published in this source record
Termination date
May 22, 2023
Distribution pattern
nationwide
UPC, lot, and code information
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).
Voluntary or mandated
Voluntary: Firm initiated
Initial notification method
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Source last updated
Not tracked separately from the Public Health Trace retrieval date below
Public Health Trace retrieval date

Other products recalled under this same event

This recall shares FDA event ID 90203 with 2 other product entries in Public Health Trace.

FDA Recall United States Terminated Historical recordClass II

EarthLab Inc

Product
Wise Woman Herbals Standardized Kava Glycerite, product is l…
Published
June 29, 2022
Distribution
Nationwide

View recall →

FDA Recall United States Terminated Historical recordClass II

EarthLab Inc

Product
Wise Woman Herbals Kava Capsules, 450 mg Kava (Piper met. Ro…
Published
June 29, 2022
Distribution
Nationwide

View recall →

Responsible company: EarthLab Inc

Other recalls from EarthLab Inc

FDA Recall United States Terminated Historical recordClass II

EarthLab Inc

Product
Wise Woman Herbals Standardized Kava Glycerite, product is l…
Published
June 29, 2022
Distribution
Nationwide

View recall →

FDA Recall United States Terminated Historical recordClass II

EarthLab Inc

Product
Wise Woman Herbals Kava Capsules, 450 mg Kava (Piper met. Ro…
Published
June 29, 2022
Distribution
Nationwide

View recall →

Where this information comes from

View FDA enforcement record -- the specific openFDA record this summary was built from.

No separate FDA public notice was found for this enforcement record. The information below comes from FDA's Recall Enterprise System through openFDA.

FDA Enforcement Reports -- FDA's general, official recall and enforcement information.

Technical source data

View raw source data -- the machine-readable record this page's information was built from.

Retrieved by Public Health Trace:

Frequently asked questions

What does a Class II mean?

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

Is this recall still active?

According to FDA, this recall's status is "Terminated." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.

What should I do if I have this product?

Follow the instructions published by the responsible agency (see the source links below) -- recall guidance (e.g. dispose of the product, return it for a refund, or check for a specific lot number) varies by recall and is set by that agency, not by Public Health Trace.

Where can I find more official information?

The source links below, published by FDA, are the authoritative record for this recall, including any updates issued after this summary was retrieved.

This summary is based on the official source record referenced above. Public Health Trace does not state that any company or product is unsafe beyond what the official source has published. Read the full medical disclaimer.