Sandoz Inc recalls Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal CDM
Recalled June 24, 2026 · FDA recall D-0608-2026 · Sandoz
Hazard
Labeling: Incorrect or Missing Lot and/or Exp Date · FDA Class III
Units
7,803 bottles
Sold at
U.S. Nationwide
Description
Labeling: Incorrect or Missing Lot and/or Exp Date
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
Manufacturer(s)
Sandoz Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →