Focalin XR (dexmethylphenidate HCl) 5 mg, 30… was recalled on June 1, 2026 in cooperation with the U.S. Food and Drug Administration because labeling: Incorrect or Missing Lot and/or Exp Date.
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
Lot VA0099422; Exp. Date June 30, 2028
Units affected: 7,803 bottles
Where it was sold: U.S. Nationwide
Compare the codes above against the label on your product — usually on the bottom, the back panel, or the packaging. If your unit isn't listed, it is not part of this recall.
Labeling: Incorrect or Missing Lot and/or Exp Date
Class III means the product is unlikely to cause a health problem, but it violates FDA labeling or manufacturing rules.
Stop using the product. Return it to the place of purchase for a refund, or dispose of it. Contact the recalling firm with questions.
Contact: Recalling firm: Sandoz Inc
Not sure what you're entitled to? Read our guide: what to do if your product is recalled.
Always confirm details on the official notice from the U.S. Food and Drug Administration before acting.
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Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
Potential foreign object contamination: rubber pieces
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