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
- Mouthwash
- Model numbers
- Lot #: 250505P9
- 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 Mouthwash is designed for children, providing a fun bubblegum flavor to encourage dental hygiene. Parents often purchase it to promote good oral care habits in kids.
Why This Is Dangerous
The cGMP deviations indicate that the manufacturing process may have compromised the product's safety and quality. This can lead to potential contamination or ineffective ingredients in the mouthwash.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers may face safety concerns regarding the effectiveness and safety of the mouthwash, leading to a need for immediate disposal or return.
Practical Guidance
How to identify if yours is affected
- Check the bottle for the Lot #: 250505P9.
- Verify the expiration date as 05/27.
- Look for any labeling that identifies the product as ORL Kids Mouthwash.
Where to find product info
The Lot number and expiration date are typically found near the bottom of the bottle or on the label.
What timeline to expect
Expect a refund or guidance response within 4-6 weeks.
If the manufacturer is unresponsive
- Follow up with Signature Formulations via e-mail.
- Document all communication attempts for your records.
How to prevent similar issues
- Check for cGMP compliance when purchasing health products.
- Look for certifications from health authorities.
- Research product recalls before purchasing.
Documentation advice
Keep receipts, product packaging, and any correspondence regarding the recall as records.
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Product Details
The affected product is ORL Kids Mouthwash, Bubblegum Flavor, packaged in 16.9 oz. (500ml) bottles. Model Lot #: 250505P9 with an expiration date of 05/27 is part of the recall. It was distributed in Arizona only.
Key Facts
- Distributed in Arizona only
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Safety Guide
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