Why it was recalled
cGMP Deviations
Product description
ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC, Scottsdale, Arizona USA
Lot numbers, UPCs & expiration codes
Lot #: 250505P9, Exp. Date 05/27
Where it was sold
AZ only
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0252-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Dec 8, 2025
- FDA report date
- Jan 14, 2026
- Quantity
- 570 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Signature Formulations, LLC
Original FDA data
Every field from FDA enforcement report D-0252-2026, exactly as published.
Show all FDA fields
- City
- Phoenix
- State
- AZ
- Status
- Ongoing
- Country
- United States
- Event ID
- 98131
- Address
- 5446 W Roosevelt St Ste 101
- Code information
- Lot #: 250505P9, Exp. Date 05/27
- Postal code
- 85043-2729
- Report date
- Jan 14, 2026
- Product type
- Drugs
- Recall number
- D-0252-2026
- Classification
- Class II
- Recalling firm
- Signature Formulations, LLC
- Product quantity
- 570 bottles
- Reason for recall
- cGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC, Scottsdale, Arizona USA
- Distribution pattern
- AZ only
- Recall initiation date
- Dec 8, 2025
- Initial firm notification
- Center classification date
- Jan 5, 2026