FDA Class III · Drug · June 24, 2026
Focalin XR (dexmethylphenidate HCl) 5 mg recall — Sandoz Inc
Labeling: Incorrect or Missing Lot and/or Exp Date
Official ID D-0608-2026 · Official record ↗
Focalin XR (dexmethylphenidate HCl) 5 mg: recall status
⚠ Recall found. Focalin XR (dexmethylphenidate HCl) 5 mg is named in 1 official recall in our current data. Details and the official notices are below — act on the remedy in the official notice.
Recalls naming this model
Verify with the official sources:
- CPSC — consumer products ↗ (aggregated here)
- NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
- FDA — food, drugs, medical devices ↗ (aggregated here)
- USDA FSIS — meat, poultry & egg products ↗ (not yet aggregated here)
- Recalls.gov — the U.S. government’s all-agency portal ↗
Found something wrong or missing? Report a data error.
Compiled from official public-domain CPSC, NHTSA, and FDA data. Sources last checked July 24, 2026 at 1:09 AM UTC.