Recall Weekly
Moderate riskFDA DrugClass II

ORL Kids Bubblegum mouthwash recalled for manufacturing deviations

ORL Kids Mouthwash in Bubblegum flavor did not meet FDA manufacturing standards during production. The issue affects 570 bottles distributed in Arizona with lot number 250505P9 and expiration date 05/27. No injuries have been reported.

From the FDA notice · Read the official notice ↗

What to do

  1. Check if you have ORL Kids Mouthwash Bubblegum with lot #250505P9
  2. Stop using the product if you have this lot
  3. Dispose of the mouthwash or return it to where you purchased it
  4. Contact ORL Labs, LLC with questions about the recall
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC, Scottsdale, Arizona USA
Sold in
AZ only
Made for
Children (3 years to 12 years)

This recall covers 2 products — see all of them.

Details

Units affected
570 bottles
Illnesses reported
None reported
Manufactured in
5446 W Roosevelt St Ste 101, Phoenix, AZ, United States
Classification
Class II
Recall number
D-0252-2026

In the FDA's words

Description
ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC, Scottsdale, Arizona USA cGMP Deviations Lot #: 250505P9, Exp. Date 05/27 Distribution: AZ only Affected quantity: 570 bottles
Hazard
cGMP Deviations

2 products in this recall

ORL Kids bubblegum mouthwash, toothpaste recalled for manufacturing quality issues

ORL Labs is recalling two ORL Kids bubblegum-flavored products: a 16.9 oz mouthwash and a 4 oz natural toothpaste. The products were not made under the required current good manufacturing practices, which are the quality standards for making drugs. The recall covers products distributed only in Arizona, and no injuries have been reported.

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

Related topics

OtherDrugsBaby & kidsAZMore from FDA Drug