← FDA ENFORCEMENT
D-0252-2026Class II
Signature Formulations, LLC
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
Signature Formulations, LLC
Product type
Drug
Status
Ongoing
Report date
2026-01-14
Distribution
AZ only
Firm state
AZ
Product quantity
570 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPAReason for recall
cGMP Deviations
Product description
ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC, Scottsdale, Arizona USA
Code / lot info
Lot #: 250505P9, Exp. Date 05/27
Other recalls SPEQ maps to Risk Management & CAPA
2026-10-21Class IIHouston Rx LLC2026-10-21Class IICook Incorporated2026-10-21Class IIBaxter Healthcare Corporation2026-10-14Class IIQUANTUM OPS Inc
See all Risk Management & CAPA recalls →Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →