ORL Kids toothpaste recalled for cGMP manufacturing deviations
ORL Labs recalled ORL Kids Natural Toothpaste in Bubblegum Flavor due to deviations from manufacturing quality standards (cGMP). The affected product is Lot #250520P4 with expiration date 05/27, distributed in Arizona. No injuries have been reported.
From the FDA notice · Read the official notice ↗
What to do
- Check if you have ORL Kids Natural Toothpaste, Bubblegum Flavor, 4 oz with Lot #250520P4 and expiration date 05/27
- Stop using the product if you have this lot
- Dispose of the toothpaste or return it to the place of purchase
- Contact ORL Labs or your healthcare provider with questions
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- ORL Kids Natural Toothpaste, Bubblegum Flavor, 4 oz (120ml), ORL Labs, LLC, Scottsdale, Arizona USA
- Sold in
- AZ only
- Made for
- Children (0 months and older)
This recall covers 2 products — see all of them.
Details
- Units affected
- 1,458 containers
- Illnesses reported
- None reported
- Manufactured in
- 5446 W Roosevelt St Ste 101, Phoenix, AZ, United States
- Classification
- Class II
- Recall number
- D-0253-2026
In the FDA's words
- Description
- ORL Kids Natural Toothpaste, Bubblegum Flavor, 4 oz (120ml), ORL Labs, LLC, Scottsdale, Arizona USA cGMP Deviations Lot #: 250520P4, Exp. Date 05/27 Distribution: AZ only Affected quantity: 1,458 containers
- 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.
- ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC, Scottsdale, Arizona USAD-0252-2026 · 570 bottles
- ORL Kids Natural Toothpaste, Bubblegum Flavor, 4 oz (120ml), ORL Labs, LLC, Scottsdale, Arizona USA (this page)D-0253-2026 · 1,458 containers