ORL Kids Natural Toothpaste, Bubblegum Flavor, 4 oz (120ml), ORL Labs
Recalled by Signature Formulations, LLC
Drug recall
Signature Formulations, LLC
Class II — moderate
Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
Signature Formulations, LLC has recalled ORL Kids Natural Toothpaste, Bubblegum Flavor, 4 oz (120ml), ORL Labs, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on January 14, 2026 and was initiated on December 8, 2025. It is classified as a Class II recall, which means using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.
What was recalled?
This recall covers ORL Kids Natural Toothpaste, Bubblegum Flavor, 4 oz (120ml), ORL Labs, with approximately 1,458 containers affected. The company behind the recall is Signature Formulations, LLC, based in Phoenix, AZ. The FDA describes the product as: “ORL Kids Natural Toothpaste, Bubblegum Flavor, 4 oz (120ml), ORL Labs, LLC, Scottsdale, Arizona USA”
Why was ORL Kids Natural Toothpaste, Bubblegum Flavor, 4 oz (120ml), ORL Labs recalled?
According to the FDA, the stated reason for the recall is: “cGMP Deviations.” In plain terms, this recall relates to a manufacturing quality issue (CGMP).
CGMP stands for Current Good Manufacturing Practice — the FDA's quality rules for how medicines must be made, tested, and documented. A CGMP-related recall means the manufacturing process did not meet those standards. It does not automatically mean the medicine is harmful, but the FDA cannot be confident in its quality, so it is removed from the market.
What should you do?
If you think you may have bought ORL Kids Natural Toothpaste, Bubblegum Flavor, 4 oz (120ml), ORL Labs, compare it against the product description and identifying codes (Lot #: 250520P4, Exp. Date 05/27) before using it. This recall is currently listed as ongoing.
The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Signature Formulations, LLC or your local health authority.
About this recall
This recall was distributed in AZ. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.
Full recall details
- Status
- Ongoing
- Date reported
- January 14, 2026
- Recall started
- December 8, 2025
- Distributed in
- AZ
What you can do
Check whether any product you have matches the description and codes above. If it does, stop using it and follow the instructions in the official recall notice. When in doubt, contact the company or your local health authority.
Quick answers
Why was ORL Kids Natural Toothpaste, Bubblegum Flavor, 4 oz (120ml), ORL Labs recalled?+
According to the FDA: cGMP Deviations
How serious is this recall?+
Class II — moderate. Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
What should I do if I have ORL Kids Natural Toothpaste, Bubblegum Flavor, 4 oz (120ml), ORL Labs?+
Compare your product against the description and identifying codes on this page. If it matches, stop using it and follow the instructions in the official recall notice — this usually means returning it for a refund or discarding it. When in doubt, contact the company or your local health authority.
Opens the U.S. Food and Drug Administration (FDA) data for this recall.
Recall number: D-0253-2026. Information last synced from the FDA on July 6, 2026.