Sandoz Inc: Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal CDMO Gaine…
| Source | FDA · Drugs |
|---|---|
| Date | 2026-06-24 |
| 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 / hazard | Labeling: Incorrect or Missing Lot and/or Exp Date |
| Classification | Class III |
| Official notice | — |
| Record ID | fda-drug:D-0608-2026 |