Sandoz Inc: Focalin Xr (dexmethylphenidate Hcl) 5 Mg, 30 Extended-release Capsules Per Bottle

Sandoz Inc is recalling Focalin XR 5 mg extended-release capsules because some bottles have incorrect or missing lot numbers and expiration dates on the label. The recall affects bottles distributed nationwide across all U.S. states and Washington D.C. Patients who have this medication should check their bottle label for the lot number and expiration date.

Recalling firm

Sandoz Inc

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

Reason

Labeling: Incorrect or Missing Lot and/or Exp Date

Category

drug recall

Country

United States

Agency

U.S. Food and Drug Administration

Recall date

2026-06-01

Status

Ongoing

Areas affected

AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...

Distribution

U.S. Nationwide

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/6dd563e8-0e2c-4e5d-84ef-7b1a382e5ba7