Notice names this product. Sandoz’s Focalin XR (dexmethylphenidate HCl) 5 mg is named in FDA Class III recall D-0608-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: Labeling: Incorrect or Missing Lot and/or Exp Date Identifying details: Lot VA0099422; Exp. Date June 30, 2028. Units affected: 7,803 bottles. Status: Ongoing.
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
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
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
Labeling: Incorrect or Missing Lot and/or Exp Date
Company / brand: Sandoz recalls
Affected product: Focalin XR (dexmethylphenidate HCl) 5 mg recall status
Official ID D-0608-2026 · Official record ↗
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Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 6:00 PM UTC.