FDAFDA · Food and drugs·Recall number D-0608-2026
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
Published June 24, 2026 · Recall initiated: June 1, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling: Incorrect or Missing Lot and/or Exp Date
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- FOCALIN
- Manufacturer
- Sandoz Inc
- Distributor
- U.S. Nationwide
- Lot
- Lot VA0099422; Exp. Date June 30, 2028
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.