Recall: D-0608-2026

Class III - Minor Violations

Class IIIClassification

2026-06-01Initiated

OngoingStatus

Sandoz IncFirm

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

Labeling: Incorrect or Missing Lot and/or Exp Date

Distribution

U.S. Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.