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

Recall Summary Sandoz Inc is recalling Focalin XR 5 mg extended-release capsules (NDC 66758-235-31) distributed nationwide because some bottles have incorrect or missing lot numbers and expiration dates on their labels. This recall affects the ADHD medication in 30-capsule bottles manufactured by Societal CDMO Gainesville, LLC. The recall is classified as Class III, indicating a low probability of serious health consequences.

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/f9c9f1d7-cb60-48a5-956c-fe875f17616c