Quick Facts at a Glance
- Recall Date
- December 8, 2025
- Hazard Level
- HIGH
- Brand
- ORL Labs
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- CHILDREN
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- ORL Labs
- Product type
- Children's Toothpaste
- Model numbers
- Lot #: 250520P4, Exp. Date 05/27
- Sold at
- Unknown
- Where affected
- AZ
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 8, 2025
Reported by FDA DRUG
January 14, 2026
RecallRadar source check
January 21, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
cGMP Deviations
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Signature Formulations, LLC or your healthcare provider for guidance. Notification method: E-Mail
About This Product
ORL Kids Natural Toothpaste is designed for children's dental care, featuring a bubblegum flavor to encourage kids to maintain oral hygiene. Parents often purchase this product for its natural ingredients and appealing taste.
Why This Is Dangerous
The cGMP deviations may lead to inconsistent product quality, potentially affecting safety and effectiveness. This could result in adverse health effects if consumed regularly by children.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall restricts access to a specific children's toothpaste, which may require parents to seek alternative dental care products quickly.
Practical Guidance
How to identify if yours is affected
- Check the product packaging for the lot number.
- Verify the expiration date on the tube.
- Stop using the product if it matches the recalled lot.
Where to find product info
The lot number and expiration date can be found printed on the back or bottom of the toothpaste tube.
What timeline to expect
Expect a refund or replacement processing time of approximately 4-6 weeks.
If the manufacturer is unresponsive
- Follow up via email with Signature Formulations, LLC.
- Document all communication attempts for your records.
How to prevent similar issues
- Look for toothpaste certified by dental associations in the future.
- Choose products with clear labeling and cGMP compliance.
- Research brands for safety records before purchasing.
Documentation advice
Keep receipts, product packaging, and any correspondence related to the recall.
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Product Details
The recalled product is ORL Kids Natural Toothpaste, Bubblegum Flavor, 4 oz (120ml). It is identified by Lot #: 250520P4 and has an expiration date of 05/27. The product was distributed in Arizona.
Key Facts
- Recalled product: ORL Kids Natural Toothpaste, Bubblegum Flavor
- Recall date: December 8, 2025
- Quantity recalled: 1,458 containers
- Distribution limited to Arizona
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Safety Guide
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