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Class III · Lower riskActive recall

Focalin

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot VA0099422; Exp. Date June 30, 2028
Where it was soldU.S. Nationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Labeling: Incorrect or Missing Lot and/or Exp Date

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made bySocietal CDMO Gainesville, LLC, Gainesville, GA 30504
Brand nameFOCALIN
Generic nameDEXMETHYLPHENIDATE HYDROCHLORIDE
Active ingredient(s)DEXMETHYLPHENIDATE HYDROCHLORIDE
Distributed by / forSandoz Inc
NDC66758-235-31
Show the full FDA record
Full product labelFocalin 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 firmSandoz Inc
DistributionU.S. Nationwide
Quantity7,803 bottles
Recall initiated2026-06-01
Report date2026-06-24
Recall completed—
Recall numberD-0608-2026
ClassificationClass III
FDA statusOngoing
Origin on filePrinceton NJ United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.