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High RiskFDAfda-F-1348-2022STERILITY ISSUE

Wise Woman Herbals Sleepytime Glycerite. Product is liquid and strength is 20% presence in formula. Dosage: 60 drops 1-4 times a day. ...

Units Affected
1
Recall Date
May 11, 2022
Issuing Agency
Hazard
Sterility Issue

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-F-1348-2022.

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

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-F-1348-2022.

Recall terminated by FDA.

✅ What you should do

  1. Stop using the product if you own it.
  2. Check the model number, lot code, or sell-by date against the recall notice above.
  3. Contact Earthlab Inc or the retailer where you bought it for a refund, replacement, or repair.
  4. For the most current official instructions, visit the FDA recall page.
  5. If you've been hurt by this product, report the incident to FDA.

Consumer Contact (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-F-1348-2022.

EarthLab Inc

FDA

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📣 Report a food, supplement, or cosmetic problem to the FDA

If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.

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Earthlab Inc Recall FAQ

Earthlab Inc is the subject of a baby food & formula safety report: Wise Woman Herbals Sleepytime Glycerite. Product is liquid and strength is 20% presence in formula. Dosage: 60 drops 1-4 times a day. .... The notice was published on May 11, 2022 by the U.S. Food and Drug Administration (FDA). Approximately 1 units are potentially affected.