Official recall notice

FDA DrugClass IIINotable

FDA Recall: Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufact

Recall date
2026-06-24
Category
Drug
FDA class
Class III

Why it was recalled

Hazard

Labeling: Incorrect or Missing Lot and/or Exp Date

Recommended action

What to do

7,803 bottles

Product description

Labeling: Incorrect or Missing Lot and/or Exp Date

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