Recall RadarFocalin 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
Labeling: Incorrect or Missing Lot and/or Exp Date
Read the official FDA notice →What to do
Stop using the product and check it against the description above. Follow the remedy on the official notice; most recalls are refunded or replaced without a receipt. If you or a family member has already been affected, keep the packaging and the lot code — they're what a claim rests on later.
Details
- Recalling company
- Sandoz Inc — Princeton, NJ
- Severity
- Class III — low
- Reported
- June 24, 2026
- Quantity
- 7,803 bottles
- Recall number
- D-0608-2026
- Status
- Ongoing
- Source
- FDA
Where it went
U.S. Nationwide
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