FDAHealthJune 1, 2026
Sandoz Inc — 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
⚠️ Labeling: Incorrect or Missing Lot and/or Exp Date
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 1, 2026
U.S. Nationwide
What's affected?
- 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
- Brand
- FOCALIN
- Lot code
- VA0099422
Additional details
Lot VA0099422; Exp. Date June 30, 2028
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 7,803 bottles.
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