Class III Recall

Sandoz Inc

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
Classification
Class III
Status
Ongoing
Lot
Lot VA0099422; Exp. Date June 30, 2028
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.