Class III

Drug Recall: 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

Sandoz Inc · June 1, 2026

Reason for Recall

Labeling: Incorrect or Missing Lot and/or Exp Date

Distribution

U.S. Nationwide

States Affected

NATIONWIDE

Quantity Affected

7,803 bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0608-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Sandoz Inc Drug Recall: 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 | SafeCheck