Class IITerminated in FDA datasetRecall initiated May 11, 2022

Wise Woman Herbals Sleepytime Glycerite. Product is liquid and strength is 20% presence in…

Recalling firm: EarthLab Inc

Why it was recalled

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

Historical recall record. This is not a new recall announcement. “Terminated” describes the FDA recall process; it does not certify that an individual package is safe. FDA termination date: May 22, 2023.

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ProductWise 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
Package size2oz
UPC748840142732

FDA 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).

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Full FDA record and distribution details

Original 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

Extracted codes and context

TypeCode / valueContext
UPC7488401427327 48840 14270 1 8 oz UPC 7 48840 14271 8 16 oz UPC 7 48840 14272 5 32 oz UPC 7 48840 14273 2
lot10/19/23ts: 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

Original FDA recall reason

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

Recall details

Recall number
F-1348-2022
Event ID
90203
FDA status
Terminated
Initiated
May 11, 2022
Reported
Jun 29, 2022
Classified
Jun 22, 2022
Terminated
May 22, 2023
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
Location
Creswell, OR, United States
Initiation type
Voluntary: Firm initiated
Notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Where it was distributed

nationwide

FDA source record · F-1348-2022

Data updated September 16, 2026. View official FDA data ↗

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