Recall Weekly
Moderate riskFDA DrugClass II

ORL Kids Bubblegum Mouthwash recalled for cross-contamination

ORL Labs LLC is recalling ORL Organic Oral Care Bubblegum Kids Mouthwash, 16.9 oz. FDA sampling found progesterone, estradiol or dehydroepiandrosterone (DHEA) in the product, which the agency lists as cross-contamination. No injuries have been reported.

From the FDA notice · Read the official notice ↗

What to do

  1. Stop using the mouthwash, and do not give it to children.
  2. Check the lot number on the bottle: 241029P9, 250505P9, 250520P9 or 260406P9, with an expiration date between 9/26 and 8/28. UPC: 850006245475.
  3. The notice doesn't say how to get a refund or replacement; contact ORL Labs LLC or where you bought it.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
ORL Organic Oral Care Bubblegum Kids Mouthwash, 16.9 oz., ORL, ORL Labs, LLC, Scottsdale, Arizona, USA, UPC# #850006245475
UPC code
  • 850006245475
Sold in
Nationwide
Made for
Children (0 months and older)

This recall covers 6 products — see all of them.

Details

Units affected
3116 units
Illnesses reported
None reported
Manufactured in
16445 N 91st St, Scottsdale, Arizona, United States
Classification
Class II
Recall number
D-0178-2027

In the FDA's words

Description
ORL Organic Oral Care Bubblegum Kids Mouthwash, 16.9 oz., ORL, ORL Labs, LLC, Scottsdale, Arizona, USA, UPC# #850006245475 Cross-contamination: The firm was notified by the FDA of sampling results which found the presence of progesterone, estradiol, or dehydroepiandrosterone (DHEA) Lots 241029P9, 250505P9, 250520P9 & 260406P9, any Expiration Date between 9/26 and 8/28. Distribution: USA nationwide Affected quantity: 3116 units
Hazard
Cross-contamination: The firm was notified by the FDA of sampling results which found the presence of progesterone, estradiol, or dehydroepiandrosterone (DHEA)

6 products in this recall

ORL toothpaste and mouthwash recalled for hormone cross-contamination

ORL Labs is recalling six ORL Organic Oral Care kids' and adult toothpaste and mouthwash products sold nationwide. The FDA's sampling found progesterone, estradiol, or DHEA (a hormone) in the products, which the company says is due to cross-contamination. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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