FDA recall, , Moderate risk
ORL Kids Mouthwash and Natural Toothpaste
Signature Formulations is recalling its ORL Kids Mouthwash and ORL Kids Natural Toothpaste because of cGMP deviations.
Summary by Recall Canary from the FDA notice
What happened
Signature Formulations, LLC of Phoenix, Arizona, recalled ORL Kids Natural Toothpaste, Bubblegum Flavor, 4 oz (120ml), and ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, both distributed by ORL Labs, LLC, Scottsdale, Arizona USA. The FDA stated the reason as cGMP Deviations. The company began the recall on December 8, 2025, and the FDA added it to the Enforcement Report and classified it on January 5, 2026. Distribution was AZ only.
2 photos
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is your bottle affected?
2 products
Affected if its lot code is listed.
ORL Kids Natural Toothpaste, Bubblegum Flavor, 4 oz (120ml), ORL Labs, LLC, Scottsdale, Arizona USA
- Lot code
- 250520P4
ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC, Scottsdale, Arizona USA
- Lot code
- 250505P9
Recall details
- Company began the recall
- Sold in
- Company
- Signature Formulations, LLCPhoenix, Arizona
- Hazard
- Manufacturing problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98131
- Recall numbers
- D-0252-2026 to D-0253-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
