ORL Kids Natural Toothpaste recall
FDA recall D-0253-2026 · initiated Dec 8, 2025
Signature Formulations, LLC recalled ORL Kids Natural Toothpaste in Dec 2025 — an FDA Class II recall (D-0253-2026) because cGMP Deviations.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
cGMP Deviations
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 1,458 containers
Details
- Product
- ORL Kids Natural Toothpaste, Bubblegum Flavor, 4 oz (120ml), ORL Labs, LLC, Scottsdale, Arizona USA
- Recalling company
- Signature Formulations, LLC
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- AZ only
- Initiated
- Dec 8, 2025
- FDA report date
- Jan 14, 2026
Frequently asked
- Was ORL Kids Natural Toothpaste recalled?
- Signature Formulations, LLC recalled ORL Kids Natural Toothpaste in Dec 2025 — an FDA Class II recall (D-0253-2026) because cGMP Deviations. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was ORL Kids Natural Toothpaste recalled?
- Per the FDA enforcement record, the reason for recall D-0253-2026 was: cGMP Deviations
- Is a recalled ORL Kids Natural Toothpaste dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of ORL Kids Natural Toothpaste are affected?
- Distributed: AZ only. The recall covers these lots — Lot #: 250520P4, Exp. Date 05/27. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0253-2026.