The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Food)·F-1348-2022·Announced 2022-06-29

Wise Woman Herbals Sleepytime Glycerite Recalled for Yeast and Mold Contamination

EarthLab Inc is recalling Wise Woman Herbals Sleepytime Glycerite due to elevated yeast and mold levels detected in microbial testing. Consumers should discontinue use.

The agency’s classification

FDA (Food): Class II

Class II is 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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II classification without reported illnesses or injuries. Yeast and mold contamination is lower-risk compared to serious pathogens like Listeria or Salmonella. The recall appears precautionary based on out-of-specification test results.

Plain-English summary

EarthLab Inc is recalling Wise Woman Herbals Sleepytime Glycerite, a liquid herbal supplement, because microbial testing found the product to contain high yeast and mold counts exceeding acceptable specifications. The affected product is distributed nationwide.

The recall includes bottles in 2 oz, 4 oz, 8 oz, 16 oz, and 32 oz sizes with the following lot codes: 17950, 17724, 17648, 17338, 17019, 16963, and 16905. Consumers can identify affected batches by the lot code printed on the package.

Consumers who have purchased this product should discontinue use immediately. Contact EarthLab Inc or consult a healthcare provider if you have consumed the product and have health concerns.

The recalled product

Product
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…
Manufacturer
EarthLab Inc
Category
Drug — Herbal Supplement
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (19)

  • 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

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by EarthLab Inc under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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