Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal CDMO Gainesville, LLC, Gainesville, GA 30504. NDC: 66758-235-31

Recall Number: D-0608-2026

Firm: Sandoz Inc

Classification: Class III

Status: Ongoing

Report Date: 20260624

Initiation Date: 20260601

Termination Date:

Labeling: Incorrect or Missing Lot and/or Exp Date

Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal CDMO Gainesville, LLC, Gainesville, GA 30504. NDC: 66758-235-31