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

FDA recall notice · announced June 24, 2026 · Sandoz

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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

Reason for recall

Labeling: Incorrect or Missing Lot and/or Exp Date

Notes

Distribution: U.S. Nationwide
Lot/code information: Lot VA0099422; Exp. Date June 30, 2028
Quantity: 7,803 bottles
Status: Ongoing
Products in this recall event:
- 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 (D-0608-2026)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.