Recall Weekly
Moderate riskFDA DrugClass II

Organic Oral Care mouthwash recalled for hormone cross-contamination

FDA sampling found progesterone, estradiol, or DHEA (a hormone) in ORL Labs' Organic Oral Care Cinnamint Kids Mouthwash, which the firm attributes to cross-contamination. The recall covers 6,140 units distributed nationwide in the USA. No injuries have been reported.

From the FDA notice · Read the official notice ↗

What to do

  1. Stop using the mouthwash and keep it away from children.
  2. Check the lot number on the bottle: lots 241101P10 and 241212P10 are affected, with any expiration date between 9/26 and 8/28 (UPC 850006245468).
  3. The notice doesn't say how to get a refund or replacement; contact ORL Labs or the store where you bought it.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Organic Oral Care Cinnamint Kids Mouthwash, 16.9 oz., ORL, ORL Labs, LLC, Scottsdale, Arizona, USA, 16.9 oz. UPC# #850006245468
UPC code
  • 850006245468
Sold in
Nationwide
Made for
Children (3 years to 12 years)

This recall covers 6 products — see all of them.

Details

Units affected
6140 units
Illnesses reported
None reported
Manufactured in
16445 N 91st St, Scottsdale, Arizona, United States
Classification
Class II
Recall number
D-0179-2027

In the FDA's words

Description
Organic Oral Care Cinnamint Kids Mouthwash, 16.9 oz., ORL, ORL Labs, LLC, Scottsdale, Arizona, USA, 16.9 oz. UPC# #850006245468 Cross-contamination: The firm was notified by the FDA of sampling results which found the presence of progesterone, estradiol, or dehydroepiandrosterone (DHEA) Lots 241101P10 & 241212P10, any Expiration Date between 9/26 and 8/28. Distribution: USA nationwide Affected quantity: 6140 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.

Related topics

HormonesUnapproved drugsDrugsBaby & kidsSold nationwideMore from FDA Drug