Data Composite

Recall D-0608-2026

US Class III Ongoing · initiated 2026-06-01

Recalling firm

Sandoz Inc, NJ

Product

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

Reason for recall

Labeling: Incorrect or Missing Lot and/or Exp Date

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