FDA Drug Recalls

Recalls / Class II

Class IID-0252-2026

Product

ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC, Scottsdale, Arizona USA

Affected lot / code info
Lot #: 250505P9, Exp. Date 05/27

Why it was recalled

cGMP Deviations

Recalling firm

Firm
Signature Formulations, LLC
Notification channel
E-Mail
Type
Voluntary: Firm initiated
Address
5446 W Roosevelt St Ste 101, Phoenix, Arizona 85043-2729

Distribution

Quantity
570 bottles
Distribution pattern
AZ only

Timeline

Recall initiated
2025-12-08
FDA classified
2026-01-05
Posted by FDA
2026-01-14
Status
Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0252-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.