Attention, parents and caregivers: The warning behind these two products could affect the youngest members of your family.
Teaching kids to brush their teeth properly and use mouthwash is part of good dental hygiene. While adults tend to opt for a minty fresh toothpaste, most kids probably prefer something a little more to their liking, which is why many toothpaste brands offer kid-friendly flavors like strawberry and bubblegum. But double-check your bathroom cabinet, because both a mouthwash and a toothpaste specifically geared for little ones have been recalled in one state.
Signature Formulations, LLC has issued a voluntary recall for its ORL Kids Mouthwash and ORL Kids Natural Toothpaste in bubblegum flavor due to “cGMP Deviations,” according to January 5 notices from the U.S. Food and Drug Administration (FDA). According to the FDA, cGMP refers to Current Good Manufacturing Practice regulations “that assure proper design, monitoring, and control of manufacturing processes and facilities.” A deviation can be any change from the approved process of pharmaceutical manufacturing of the product.
The recalls affect 570 bottles of mouthwash and 1,458 containers of the toothpaste distributed to one state: Arizona. The FDA provided the following details:
ORL Kids Mouthwash, Bubblegum Flavor
- 16.9 oz. (500ml) per bottle
- Lot #: 250505P9
- Expiration Date: 05/27
ORL Kids Natural Toothpaste, Bubblegum Flavor
- 4 oz (120ml) container
- Lot #: 250520P4
- Expiration Date: 05/27
While the recalls were initiated in early December 2025, the FDA recently designated both recalls as a Class II event on January 5, which signifies a situation where use of or exposure to the recalled product may cause “adverse health consequences,” but the risk of those consequences is low.
ORL is an oral health company that specializes in “natural and organic oral care,” according to its website. Its products are marketed as being fluoride-free and contain natural hydroxyapatite, organic xylitol, and plant-based essential oils, vitamins, and minerals.
It’s generally recommended to brush with a fluoride toothpaste to help prevent cavities, according to the U.S. Centers for Disease Control and Prevention (CDC). The American Dental Association recommends consulting with a dentist before using fluoride toothpaste for children under 2 years of age, and using a “pea-sized amount of fluoride toothpaste” for children 2 to 6 years old.
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