Moderate riskFDA DrugClass II

ORL Organic Fresh Mint mouthwash recalled for cross-contamination

ORL Labs LLC is recalling ORL Organic Oral Care Fresh Mint mouthwash, 16.9 oz. FDA sampling found progesterone, estradiol or dehydroepiandrosterone (DHEA) in the product due to cross-contamination. No injuries have been reported.

From the FDA notice · Read the official notice ↗

What to do

  1. Stop using the affected mouthwash.
  2. Check the lot code on the bottle against these lots: 240710P6, 240711P6, 240807P6, 241118P6, 241121P6, 250120P6, 250505P11, 250516P6, 251105P6 and 260618P6.
  3. Check that the expiration date falls between 9/26 and 8/28.
  4. The notice doesn't say how to get a refund or replacement; contact ORL Labs, LLC, in Scottsdale, Arizona.

Is yours affected?

Compare your label or packaging with the recalled product.

Product
ORL Organic Oral Care Fresh mint mouthwash, 16.9 oz., ORL, Manufactured in USA, ORL Labs, LLC, Scottsdale, Arizona, USA, UPC# #850006245451
UPC code
  • 850006245451
Sold in
Nationwide
Made for
All ages

This recall covers 6 products — see all of them.

Details

Units affected
12081 units
Illnesses reported
None reported
Manufactured in
16445 N 91st St, Scottsdale, Arizona, United States
Classification
Class II
Recall number
D-0180-2027

In the FDA's words

Description
ORL Organic Oral Care Fresh mint mouthwash, 16.9 oz., ORL, Manufactured in USA, ORL Labs, LLC, Scottsdale, Arizona, USA, UPC# #850006245451 Cross-contamination: The firm was notified by the FDA of sampling results which found the presence of progesterone, estradiol, or dehydroepiandrosterone (DHEA) Lots 240710P6, 240711P6, 240807P6, 241118P6, 241121P6, 250120P6, 250505P11, 250516P6, 251105P6 & 260618P6, any Expiration Date between 9/26 and 8/28. Distribution: USA nationwide Affected quantity: 12081 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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