Warning
Signature Formulations Recalls ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0252-2026Drug / Pharmaceutical
Signature Formulations Recalls ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz
Signature Formulations, LLC · Class II — Moderate Risk
Product Description
ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC, Scottsdale, Arizona USA
Reason for Recall
cGMP Deviations
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
AZ only
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
Signature Formulations, LLC has recalled a pharmaceutical product that the FDA classified as Class II affecting 570 bottles. The recall was initiated on December 8, 2025. cGMP Deviations. It was distributed in AZ only. Class II recalls involve products that might cause a temporary health problem or pose only a slight threat of a serious nature. Consumers should discontinue use and contact the firm.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medication Defects.