FDA-Drug2026-06-24Class IIIMISBRANDING
Sandoz Focalin XR 5 mg recalled for missing or incorrect lot and expiration date labels
What this means
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.
The agency's original wording
Hazard
Labeling: Incorrect or Missing Lot and/or Exp Date
Intended for
Children (under 18 years)
Illnesses reported
None reported
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-0608-2026Want us to check the next one for you?
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