FDA-Drug2026-06-24Class IIIMISBRANDING

Sandoz Focalin XR 5 mg recalled for missing or incorrect lot and expiration date labels

EXPIRATION DATE ERRORNationwide distribution

Sandoz Focalin XR 5 mg recalled for labeling error

Sandoz is recalling one lot of Focalin XR (dexmethylphenidate HCl) 5 mg extended-release capsules because some bottles have incorrect or missing lot numbers and expiration dates on the label. The affected lot (VA0099422) was distributed nationwide. This is a labeling issue only; the medication itself has not been found to be unsafe.

  • Check your Focalin XR bottle label for lot number VA0099422.
  • If your bottle is from this lot, contact your pharmacy or healthcare provider before using it.
  • Do not discard the medication without guidance from your pharmacist or doctor.
Hazard

Labeling: Incorrect or Missing Lot and/or Exp Date

Sold states
U.S. Nationwide
Affected count
7,803 bottles
Manufactured in
100 College Rd W, Princeton, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0608-2026

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