REGULATORY INTELLIGENCE·Warning Letter
Signature Formulations, LLC Faces FDA Class II Recall for ORL Kids Mouthwash Due to cGMP Deviations
Signature Formulations, LLC initiated a Class II recall of 570 bottles of ORL Kids Mouthwash, Bubblegum Flavor, due to cGMP deviations. This Phoenix, AZ-based firm's action underscores critical compliance risks in contract manufacturing. Procurement and regulatory teams must enhance supplier oversight to mitigate similar disruptions and protect brand integrity in the oral care sector.
90-Day Activity
Signature Formulations, LLC
RMRohan Mehta· Senior Supply Chain Intelligence Analyst2026-01-14