ORL Kids Natural Toothpaste, Bubblegum Flavor, 4 oz (120ml), ORL Labs, LLC, Scottsdale, Arizona USA
Summary
The FDA issued a Class II for ORL Kids Natural Toothpaste, Bubblegum Flavor, 4 oz (120ml), ORL Labs, LLC, Scot by Signature Formulations, LLC. Reason: cGMP Deviations.
Details
Source
Drug Recall
External ID
D-0253-2026
Action Date
2026-01-14
Status
Ongoing
Category
drug
Product Description
ORL Kids Natural Toothpaste, Bubblegum Flavor, 4 oz (120ml), ORL Labs, LLC, Scottsdale, Arizona USA
Lot/Code Info: Lot #: 250520P4, Exp. Date 05/27
Quantity Affected: 1,458 containers
Reason for Recall
cGMP Deviations
Distribution
AZ only
Type: Voluntary: Firm initiated
Recall Initiated: 2025-12-08
Company
Phoenix, AZ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 36 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Signature Formulations, LLC has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Signature Formulations, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Signature Formulations, LLC have FDA actions?
Signature Formulations, LLC has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0253-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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