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

Sandoz Inc is recalling Focalin XR 5 mg capsules (a prescription ADHD medication) because some bottles are missing or have incorrect lot numbers and expiration dates on the label. The affected bottles were distributed nationwide to pharmacies and patients. This is a Class III recall, which means the product is unlikely to cause serious health problems but may not work as intended or could pose a quality concern.

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

Classification

Class III

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/14c16128-1e1b-44af-982c-29c39448598c