Focalin XR (dexmethylphenidate HCl) 5 mg recall
FDA recall D-0608-2026 · initiated Jun 1, 2026
Sandoz Inc recalled Focalin XR (dexmethylphenidate HCl) 5 mg in Jun 2026 — an FDA Class III recall (D-0608-2026) because Labeling: Incorrect or Missing Lot and/or Exp Date.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 7,803 bottles
Details
- 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
- Recalling company
- Sandoz Inc
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- U.S. Nationwide
- Initiated
- Jun 1, 2026
- FDA report date
- Jun 24, 2026
This recall is linked to a product we cover: Focalin XR →
Frequently asked
- Was Focalin XR (dexmethylphenidate HCl) 5 mg recalled?
- Sandoz Inc recalled Focalin XR (dexmethylphenidate HCl) 5 mg in Jun 2026 — an FDA Class III recall (D-0608-2026) because Labeling: Incorrect or Missing Lot and/or Exp Date. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Focalin XR (dexmethylphenidate HCl) 5 mg recalled?
- Per the FDA enforcement record, the reason for recall D-0608-2026 was: Labeling: Incorrect or Missing Lot and/or Exp Date
- Is a recalled Focalin XR (dexmethylphenidate HCl) 5 mg dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Focalin XR (dexmethylphenidate HCl) 5 mg are affected?
- Distributed: U.S. Nationwide. The recall covers these lots — Lot VA0099422; Exp. Date June 30, 2028. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0608-2026.